Manufacturer's Devices - Smith & Nephew Inc.

Address:




1450 Brooks Road



Memphis

Tennessee 38116

United States


Authorised Representative/ UK Responsible Person
Name: T.J.Smith and Nephew Limited
Address:

101 Hessle Road



Hull

HU3 2BN

England United Kingdom




Code/Term Type
Uncoated unicondylar knee femur prosthesisUncoated unicondylar knee femur prosthesisClass III
Coated hip femur prosthesis modularCoated hip femur prosthesis modularClass III
Rotating hinged total knee prosthesisRotating hinged total knee prosthesisClass III
Coated knee femur prosthesisCoated knee femur prosthesisClass III
Polyethylene acetabulum prosthesisPolyethylene acetabulum prosthesisClass III
Coated knee tibia prosthesisCoated knee tibia prosthesisClass III
Constrained polyethylene acetabular linerConstrained polyethylene acetabular linerClass III
Uncoated unicondylar knee tibia prosthesis polyethyleneUncoated unicondylar knee tibia prosthesis polyethyleneClass III
Orthopaedic implantation sleeve single-useOrthopaedic implantation sleeve single-useClass III
Patellofemoral joint prosthesisPatellofemoral joint prosthesisClass III
Humerus nail sterileHumerus nail sterileClass IIb
Orthopaedic cement preparation/delivery kitOrthopaedic cement preparation/delivery kitClass IIb
Acetabulum prosthesis hole plugAcetabulum prosthesis hole plugClass IIb
Metallic acetabulum prosthesisMetallic acetabulum prosthesisClass IIb
Femoral stem centralizerFemoral stem centralizerClass IIb
Internal orthopaedic fixation system cerclage wire/cable sterileInternal orthopaedic fixation system cerclage wire/cable sterileClass IIb
Cannulated surgical drill guiding pinCannulated surgical drill guiding pinClass IIb
Metallic femoral head prosthesisMetallic femoral head prosthesisClass III
Ceramic femoral head prosthesisCeramic femoral head prosthesisClass III
Orthopaedic bone screw non-bioabsorbable non-sterileOrthopaedic bone screw non-bioabsorbable non-sterileClass IIb
Acetabular augmentation implantAcetabular augmentation implantClass IIb
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass IIb
Ceramic acetabular linerCeramic acetabular linerClass III
Femoral head/stem prosthesis adaptorFemoral head/stem prosthesis adaptorClass III
Orthopaedic bone wireOrthopaedic bone wireClass IIb
Orthopaedic fixation plate non-bioabsorbable sterileOrthopaedic fixation plate non-bioabsorbable sterileClass IIb
Arthrodesis nail non-sterileArthrodesis nail non-sterileClass IIb
General external orthopaedic fixation system implantation kit single-useGeneral external orthopaedic fixation system implantation kit single-useClass IIb
Orthopaedic bone staple non-adjustable non-sterileOrthopaedic bone staple non-adjustable non-sterileClass IIb
Orthopaedic bone staple non-adjustableOrthopaedic bone staple non-adjustableClass IIb
Orthopaedic bone washer non-sterileOrthopaedic bone washer non-sterileClass IIb
Manual orthopaedic cement mixer reusableManual orthopaedic cement mixer reusableClass IIa
Manual orthopaedic cement mixer reusableManual orthopaedic cement mixer reusableClass IIa
External orthopaedic fixation system reusableExternal orthopaedic fixation system reusableClass IIa
Stereotactic surgery system probe single-useStereotactic surgery system probe single-useClass IIa
Orthopaedic cement preparation/delivery kitOrthopaedic cement preparation/delivery kitClass IIa
Orthopaedic bone screw non-bioabsorbable non-sterileOrthopaedic bone screw non-bioabsorbable non-sterileClass IIa
Acetabulum prosthesis trial prefabricated reusableAcetabulum prosthesis trial prefabricated reusableClass IIa
Cannulated surgical drill bit single-use sterileCannulated surgical drill bit single-use sterileClass IIa
Orthopaedic osteotome blade single-useOrthopaedic osteotome blade single-useClass IIa
Bone nail guidewire reusableBone nail guidewire reusableClass IIa
Orthopaedic bone washer sterileOrthopaedic bone washer sterileClass IIb
Knee femur stem prosthesisKnee femur stem prosthesisClass IIb
Uncoated hip femur prosthesis modularUncoated hip femur prosthesis modularClass III
Bone nail end-capBone nail end-capClass IIb
Arthrodesis nail sterileArthrodesis nail sterileClass IIb
Tibia nail sterileTibia nail sterileClass IIb
Femur nail sterileFemur nail sterileClass IIb
Unicondylar knee insertUnicondylar knee insertClass III
Uncoated unicondylar knee tibia prosthesis metallicUncoated unicondylar knee tibia prosthesis metallicClass III
Knee arthroplasty wedgeKnee arthroplasty wedgeClass IIb
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIb
External orthopaedic fixation system single-useExternal orthopaedic fixation system single-useClass IIb
Coated femoral stem prosthesis modularCoated femoral stem prosthesis modularClass III
Acetabulum prosthesis trial prefabricated reusableAcetabulum prosthesis trial prefabricated reusableClass III
Acetabular shellAcetabular shellClass III
Metallic femoral head prosthesisMetallic femoral head prosthesisClass IIb
Bipolar femoral head outer component hemiarthroplastyBipolar femoral head outer component hemiarthroplastyClass IIb
Polymer orthopaedic cement restrictor non-bioabsorbable sterilePolymer orthopaedic cement restrictor non-bioabsorbable sterileClass IIb
Orthopaedic fixation plate kit non-bioabsorbable non-antimicrobialOrthopaedic fixation plate kit non-bioabsorbable non-antimicrobialClass IIb
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass IIa
Orthopaedic implant aiming/guiding block reusableOrthopaedic implant aiming/guiding block reusableClass IIa
External orthopaedic fixation system single-useExternal orthopaedic fixation system single-useClass IIa
Femoral head prosthesis trialFemoral head prosthesis trialClass IIa
Bone-resection orthopaedic reamer reusableBone-resection orthopaedic reamer reusableClass IIa
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass IIa
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass IIa
Bone trephineBone trephineClass IIa
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIa
Orthopaedic implant impactorOrthopaedic implant impactorClass IIa
Surgical saw blade sagittal single-useSurgical saw blade sagittal single-useClass IIa
Orthopaedic bone wireOrthopaedic bone wireClass IIb
Acetabulum prosthesis trial prefabricated reusableAcetabulum prosthesis trial prefabricated reusableClass IIa
Orthopaedic prosthesis implantation instrument single-useOrthopaedic prosthesis implantation instrument single-useClass IIa
Surgical implant template single-useSurgical implant template single-useClass IIa
Patella prosthesis trialPatella prosthesis trialClass IIa
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Bone tap reusableBone tap reusableClass IIa
Bone tap reusableBone tap reusableClass IIa
Surgical drill chuckSurgical drill chuckClass IIa
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Acetabular orthopaedic reamerAcetabular orthopaedic reamerClass IIa
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIa
Surgical drill guide reusableSurgical drill guide reusableClass IIa
Medullary canal orthopaedic reamer flexibleMedullary canal orthopaedic reamer flexibleClass IIa
Orthopaedic broachOrthopaedic broachClass IIa
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa
Orthopaedic reamer guideOrthopaedic reamer guideClass IIa
Orthopaedic stereotactic surgery systemOrthopaedic stereotactic surgery systemClass IIa
Surgical implant/trial-implant/sizer holder reusableSurgical implant/trial-implant/sizer holder reusableClass IIa
Orthopaedic implant aiming/guiding block reusableOrthopaedic implant aiming/guiding block reusableClass IIa
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass IIa
Surgical instrument handle torque-limitingSurgical instrument handle torque-limitingClass IIa
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass IIa
Orthopaedic fixation implant alignment toolOrthopaedic fixation implant alignment toolClass IIa
External orthopaedic fixation system single-useExternal orthopaedic fixation system single-useClass IIa
Orthopaedic implant/instrument adaptor single-useOrthopaedic implant/instrument adaptor single-useClass IIa
Surgical implant template single-useSurgical implant template single-useClass IIa
Custom-made orthopaedic/craniofacial surgical guideCustom-made orthopaedic/craniofacial surgical guideClass IIa
Custom-made orthopaedic/craniofacial surgical guideCustom-made orthopaedic/craniofacial surgical guideClass IIa
Cannulated surgical drill bit single-use sterileCannulated surgical drill bit single-use sterileClass IIa
General external orthopaedic fixation system implantation kit single-useGeneral external orthopaedic fixation system implantation kit single-useClass IIa
Cannulated surgical drill guiding pinCannulated surgical drill guiding pinClass IIa
Cannulated surgical drill guiding pinCannulated surgical drill guiding pinClass IIa
Blue-light germicidal bulb/panelBlue-light germicidal bulb/panelClass IIa
Medullary canal orthopaedic reamer rigidMedullary canal orthopaedic reamer rigidClass IIa
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass IIa
Knee femur prosthesis trial reusableKnee femur prosthesis trial reusableClass IIa
Bone nail guidewire reusableBone nail guidewire reusableClass IIa
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Orthopaedic cement preparation/delivery kitOrthopaedic cement preparation/delivery kitClass IIa
Femoral stem prosthesis trialFemoral stem prosthesis trialClass IIa
Surgical/orthopaedic lavage control unitSurgical/orthopaedic lavage control unitClass IIa
General internal orthopaedic fixation system implantation kitGeneral internal orthopaedic fixation system implantation kitClass IIa
General-purpose surgical suction system vacuumGeneral-purpose surgical suction system vacuumClass IIa
General internal orthopaedic fixation system implantation kitGeneral internal orthopaedic fixation system implantation kitClass IIa
External orthopaedic fixation system single-use sterileExternal orthopaedic fixation system single-use sterileClass IIb
Orthopaedic osteotomeOrthopaedic osteotomeClass I
Orthopaedic bone boltOrthopaedic bone boltClass I
Orthopaedic bone boltOrthopaedic bone boltClass I
Surgical countersink reusableSurgical countersink reusableClass I
Bone tap reusableBone tap reusableClass I
Bone curette reusableBone curette reusableClass I
General-purpose calliper metallicGeneral-purpose calliper metallicClass I
Surgical malletSurgical malletClass I
Orthopaedic joint/limb rongeurOrthopaedic joint/limb rongeurClass I
Surgical torque wrench reusableSurgical torque wrench reusableClass I
Surgical torque wrench reusableSurgical torque wrench reusableClass I
Surgical tamp reusableSurgical tamp reusableClass I
Wire cutterWire cutterClass I
Manual orthopaedic cement mixer reusableManual orthopaedic cement mixer reusableClass I
Bone hookBone hookClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Surgical gougeSurgical gougeClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
External orthopaedic fixation system reusableExternal orthopaedic fixation system reusableClass I
Orthopaedic cement mixing bowlOrthopaedic cement mixing bowlClass I
Electrical mains power extension cableElectrical mains power extension cableClass I
Orthopaedic cement extractor manualOrthopaedic cement extractor manualClass I
General internal orthopaedic fixation system implantation kitGeneral internal orthopaedic fixation system implantation kitClass I
Manual orthopaedic bender reusableManual orthopaedic bender reusableClass I
Orthopaedic stereotactic surgery systemOrthopaedic stereotactic surgery systemClass I
Orthopaedic cement preparation/delivery kitOrthopaedic cement preparation/delivery kitClass I
Hand-held surgical retractor reusableHand-held surgical retractor reusableClass I
Surgical implant template reusableSurgical implant template reusableClass I
Orthopaedic trocar blade reusableOrthopaedic trocar blade reusableClass I
Bone fixation plate pliersBone fixation plate pliersClass I
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass I
Surgical instrument handle torque-limitingSurgical instrument handle torque-limitingClass I
Surgical power tool adaptorSurgical power tool adaptorClass I
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass I
External orthopaedic fixation system single-useExternal orthopaedic fixation system single-useClass I
External orthopaedic fixation system single-useExternal orthopaedic fixation system single-useClass I
Knee tibia prosthesis trial reusableKnee tibia prosthesis trial reusableClass I
Internal orthopaedic fixation system cerclage wire/cable sterileInternal orthopaedic fixation system cerclage wire/cable sterileClass I
Internal orthopaedic fixation system cerclage wire/cable non-sterileInternal orthopaedic fixation system cerclage wire/cable non-sterileClass I
Medical capital equipment storage bag/caseMedical capital equipment storage bag/caseClass I
Bone-coring punch reusableBone-coring punch reusableClass I
External orthopaedic fixation frame calculation softwareExternal orthopaedic fixation frame calculation softwareClass I
Orthopaedic chiselOrthopaedic chiselClass I
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass I
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass I
Orthopaedic osteotomeOrthopaedic osteotomeClass I
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass I
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass I
Bone trephineBone trephineClass I
Bone awl reusableBone awl reusableClass I
Orthopaedic bone boltOrthopaedic bone boltClass I
Orthopaedic bone boltOrthopaedic bone boltClass I
Surgical countersink reusableSurgical countersink reusableClass I
Bone tap reusableBone tap reusableClass I
Surgical drill chuckSurgical drill chuckClass I
Bone curette reusableBone curette reusableClass I
Surgical malletSurgical malletClass I
Surgical depth gauge reusableSurgical depth gauge reusableClass I
Surgical depth gauge reusableSurgical depth gauge reusableClass I
Orthopaedic joint/limb rongeurOrthopaedic joint/limb rongeurClass I
Orthopaedic implant impactorOrthopaedic implant impactorClass I
Orthopaedic implant driverOrthopaedic implant driverClass I
Orthopaedic implant driverOrthopaedic implant driverClass I
Surgical torque wrench reusableSurgical torque wrench reusableClass I
Surgical tamp reusableSurgical tamp reusableClass I
Wire cutterWire cutterClass I
Bone hookBone hookClass I
Manual goniometerManual goniometerClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Surgical drill guide obturatorSurgical drill guide obturatorClass I
Surgical instrument guard reusableSurgical instrument guard reusableClass I
Surgical instrument/endoscope cleaning utensil reusableSurgical instrument/endoscope cleaning utensil reusableClass I
Bone approximation clampBone approximation clampClass I
Bone approximation clampBone approximation clampClass I
Bone lever/elevator reusableBone lever/elevator reusableClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
Traction system spreader barTraction system spreader barClass I
Traction system spreader barTraction system spreader barClass I
Bone file/rasp manual reusableBone file/rasp manual reusableClass I
External orthopaedic fixation system reusableExternal orthopaedic fixation system reusableClass I
Orthopaedic broachOrthopaedic broachClass I
Orthopaedic osteotome blade reusableOrthopaedic osteotome blade reusableClass I
Periosteal elevator reusablePeriosteal elevator reusableClass I
Surgical instrument/implant rackSurgical instrument/implant rackClass I
Surgical flat-nosed pliersSurgical flat-nosed pliersClass I
Surgical flat-nosed pliersSurgical flat-nosed pliersClass I
General internal orthopaedic fixation system implantation kitGeneral internal orthopaedic fixation system implantation kitClass I
Manual orthopaedic bender reusableManual orthopaedic bender reusableClass I
Medical ruler reusableMedical ruler reusableClass I
Orthopaedic implantable-device cutterOrthopaedic implantable-device cutterClass I
Orthopaedic implantable-device cutterOrthopaedic implantable-device cutterClass I
Orthopaedic reamer guideOrthopaedic reamer guideClass I
Medullary canal orthopaedic reamer rigidMedullary canal orthopaedic reamer rigidClass I
Orthopaedic stereotactic surgery systemOrthopaedic stereotactic surgery systemClass I
Hand-held surgical retractor reusableHand-held surgical retractor reusableClass I
Orthopaedic knee-balance analyser non-electricalOrthopaedic knee-balance analyser non-electricalClass I
Orthopaedic knee-balance analyser non-electricalOrthopaedic knee-balance analyser non-electricalClass I
Orthopaedic trocar blade reusableOrthopaedic trocar blade reusableClass I
Orthopaedic trocar blade reusableOrthopaedic trocar blade reusableClass I
Surgical screwdriver single-use non-sterileSurgical screwdriver single-use non-sterileClass I
Bone fixation plate pliersBone fixation plate pliersClass I
Orthopaedic instrument surgical connectorOrthopaedic instrument surgical connectorClass I
Orthopaedic instrument surgical connectorOrthopaedic instrument surgical connectorClass I
Orthopaedic implant aiming armOrthopaedic implant aiming armClass I
Orthopaedic implant aiming armOrthopaedic implant aiming armClass I
Surgical implant/trial-implant/sizer holder reusableSurgical implant/trial-implant/sizer holder reusableClass I
Orthopaedic implant aiming/guiding block reusableOrthopaedic implant aiming/guiding block reusableClass I
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass I
Surgical instrument handle torque-limitingSurgical instrument handle torque-limitingClass I
Surgical instrument handle torque-limitingSurgical instrument handle torque-limitingClass I
Orthopaedic implantation sleeve reusableOrthopaedic implantation sleeve reusableClass I
Orthopaedic implantation sleeve reusableOrthopaedic implantation sleeve reusableClass I
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass I
Surgical instrument/implant depth limiterSurgical instrument/implant depth limiterClass I
Orthopaedic fixation implant alignment toolOrthopaedic fixation implant alignment toolClass I
Orthopaedic fixation implant alignment toolOrthopaedic fixation implant alignment toolClass I
Orthopaedic bone-reduction toolOrthopaedic bone-reduction toolClass I
External orthopaedic fixation system single-useExternal orthopaedic fixation system single-useClass I
Orthopaedic surgical distractor internalOrthopaedic surgical distractor internalClass I
Orthopaedic implant/instrument adaptor single-useOrthopaedic implant/instrument adaptor single-useClass I
Orthopaedic prosthesis implantation instrument single-useOrthopaedic prosthesis implantation instrument single-useClass I
Internal orthopaedic fixation system cerclage wire/cable sterileInternal orthopaedic fixation system cerclage wire/cable sterileClass I
Internal orthopaedic fixation system cerclage wire/cable non-sterileInternal orthopaedic fixation system cerclage wire/cable non-sterileClass I
Osteotomy guide reusableOsteotomy guide reusableClass I
Bone-coring punch reusableBone-coring punch reusableClass I
Surgical implant handling forcepsSurgical implant handling forcepsClass I
Surgical implant handling forcepsSurgical implant handling forcepsClass I
Surgical screwdriver single-use sterileSurgical screwdriver single-use sterileClass IIa
Cannulated surgical drill guiding pinCannulated surgical drill guiding pinClass IIb
Non-constrained polyethylene acetabular linerNon-constrained polyethylene acetabular liner Conformity Assessment Certificate ExpiredClass III
Press-fit femoral stem prosthesisPress-fit femoral stem prosthesis Conformity Assessment Certificate ExpiredClass III
Sleeve femoral/tibial extension coatedSleeve femoral/tibial extension coated Conformity Assessment Certificate ExpiredClass III
Sleeve femoral/tibial extension uncoatedSleeve femoral/tibial extension uncoated Conformity Assessment Certificate ExpiredClass III
Bone holding forcepsBone holding forcepsClass I
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
Orthopaedic implantation sleeve reusableOrthopaedic implantation sleeve reusableClass I
Surgical drill guide reusableSurgical drill guide reusableClass IIb
Instrument tray reusableInstrument tray reusableClass I
Orthopaedic implantation sleeve reusableOrthopaedic implantation sleeve reusableClass I
Bone holding forcepsBone holding forcepsClass I
Periosteal elevator reusablePeriosteal elevator reusableClass I
Surgical depth gauge reusableSurgical depth gauge reusableClass I
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass I
Bone approximation clampBone approximation clampClass I
Surgical flat-nosed pliersSurgical flat-nosed pliersClass I
Bone cutting forcepsBone cutting forcepsClass I
External orthopaedic fixation system single-useExternal orthopaedic fixation system single-useClass I
External orthopaedic fixation system single-useExternal orthopaedic fixation system single-useClass I
Surgical torque wrench reusableSurgical torque wrench reusableClass I
External orthopaedic fixation system single-useExternal orthopaedic fixation system single-useClass I
Knee tibia prosthesis trial reusableKnee tibia prosthesis trial reusableClass IIa
Orthopaedic chiselOrthopaedic chiselClass I
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass I
Orthopaedic implant impactorOrthopaedic implant impactorClass I
Orthopaedic instrument surgical connectorOrthopaedic instrument surgical connectorClass I
Orthopaedic implant aiming/guiding block reusableOrthopaedic implant aiming/guiding block reusableClass I
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass I
Orthopaedic fixation implant alignment toolOrthopaedic fixation implant alignment toolClass I
Bone-resection orthopaedic reamer reusableBone-resection orthopaedic reamer reusableClass I
Bone lever/elevator reusableBone lever/elevator reusableClass I
Surgical countersink reusableSurgical countersink reusableClass IIa
Surgical screwdriver reusableSurgical screwdriver reusableClass IIa
Orthopaedic bone wireOrthopaedic bone wireClass IIa
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa
Cannulated surgical drill bit single-use sterileCannulated surgical drill bit single-use sterileClass IIa
Bone tap single-use sterileBone tap single-use sterileClass IIa
Press-fit femoral stem prosthesisPress-fit femoral stem prosthesisClass III
Manual orthopaedic bender reusableManual orthopaedic bender reusableClass I
Suturing unit single-useSuturing unit single-useClass IIa
Uncoated knee femur prosthesis metallicUncoated knee femur prosthesis metallicClass III
Uncoated knee tibia prosthesis metallicUncoated knee tibia prosthesis metallicClass III
Polyethylene patella prosthesisPolyethylene patella prosthesisClass III
Tibial insertTibial insertClass III
Uncoated knee femur prosthesis metallicUncoated knee femur prosthesis metallic Conformity Assessment Certificate ExpiredClass III
Metallic femoral head prosthesisMetallic femoral head prosthesis Conformity Assessment Certificate ExpiredClass III
Uncoated knee tibia prosthesis polyethyleneUncoated knee tibia prosthesis polyethylene Conformity Assessment Certificate ExpiredClass III
Polyethylene patella prosthesisPolyethylene patella prosthesis Conformity Assessment Certificate ExpiredClass III
Tibial insertTibial insert Conformity Assessment Certificate ExpiredClass III
Uncoated knee tibia prosthesis metallicUncoated knee tibia prosthesis metallic Conformity Assessment Certificate ExpiredClass III
Uncoated femoral stem prosthesis one-pieceUncoated femoral stem prosthesis one-piece Conformity Assessment Certificate ExpiredClass III
Instrument tray reusableInstrument tray reusableClass I
Orthopaedic bone screw non-bioabsorbable sterileOrthopaedic bone screw non-bioabsorbable sterileClass IIb
Orthopaedic fixation plate non-bioabsorbable sterileOrthopaedic fixation plate non-bioabsorbable sterileClass IIb
Orthopaedic bone screw non-bioabsorbable non-sterileOrthopaedic bone screw non-bioabsorbable non-sterileClass IIb
Orthopaedic fixation plate non-bioabsorbable non-sterileOrthopaedic fixation plate non-bioabsorbable non-sterileClass IIb
Surgical implant template reusableSurgical implant template reusableClass IIa
Acetabular shellAcetabular shellClass III
Intraoperative bone pin/screw sterileIntraoperative bone pin/screw sterileClass IIa
Sterilization/disinfection container reusableSterilization/disinfection container reusableClass I
Surgical malletSurgical malletClass I
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass I
Bone holding forcepsBone holding forcepsClass I
General-purpose calliper metallicGeneral-purpose calliper metallicClass I
Orthopaedic implant aiming/guiding block reusableOrthopaedic implant aiming/guiding block reusableClass I