Manufacturer's Devices - Arthrex Inc

Address:




1370 Creekside Blvd



Naples

Florida 34108

United States


Authorised Representative/ UK Responsible Person
Name: Emergo Consulting (UK) Limited
Address:

Compass House Vision Park Histon c/o Cr360 – UL International



Cambridge

CB24 9BZ

England United Kingdom




Code/Term Type
Internal orthopaedic fixation system plate/screw non-bioabsorbable non-sterileInternal orthopaedic fixation system plate/screw non-bioabsorbable non-sterileClass IIb
Tendon/ligament bone anchor bioabsorbableTendon/ligament bone anchor bioabsorbableClass III
Shoulder glenoid fossa prosthesis prefabricatedShoulder glenoid fossa prosthesis prefabricatedClass III
Centrifuge bucket/tube holderCentrifuge bucket/tube holderClass IIa
Apheresis systemApheresis systemClass IIa
Bone marrow biopsy procedure kitBone marrow biopsy procedure kitClass IIa
Battery boxBattery boxClass IIa
Surgical camera holderSurgical camera holderClass IIa
Decontamination floor mat reusableDecontamination floor mat reusableClass IIa
Total shoulder prosthesisTotal shoulder prosthesisClass III
Arthroscopic probeArthroscopic probeClass IIa
Rechargeable battery packRechargeable battery packClass IIa
Suturing unit reusableSuturing unit reusableClass IIb
Coated shoulder humeral stem prosthesisCoated shoulder humeral stem prosthesisClass III
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa
Drilling power tool attachment basicDrilling power tool attachment basicClass IIa
Surgical drill chuck keySurgical drill chuck keyClass IIa
Blood centrifugation system containment kitBlood centrifugation system containment kitClass IIa
Electrical mains power cableElectrical mains power cableClass IIa
Uncoated shoulder humeral stem prosthesisUncoated shoulder humeral stem prosthesisClass III
Bone marrow biopsy needle single-useBone marrow biopsy needle single-useClass IIa
Surgical saw blade oscillating single-useSurgical saw blade oscillating single-useClass IIa
Orthopaedic bone screw non-bioabsorbable sterileOrthopaedic bone screw non-bioabsorbable sterileClass IIb
Haematological concentrate system preparation kit platelet concentrationHaematological concentrate system preparation kit platelet concentrationClass IIa
Haematological concentrate system preparation kit thrombin separationHaematological concentrate system preparation kit thrombin separationClass IIa
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass IIa
Bone graft funnelBone graft funnelClass IIa
Open-surgery electrosurgical handpiece/electrode bipolar single-useOpen-surgery electrosurgical handpiece/electrode bipolar single-useClass IIb
Arthroscopic obturatorArthroscopic obturatorClass IIa
Surgical tissue/fluid collection bag non-sterileSurgical tissue/fluid collection bag non-sterileClass IIa
Orthopaedic surgery tissue debris collector reusableOrthopaedic surgery tissue debris collector reusableClass IIa
Laparoscopic trocar blade reusableLaparoscopic trocar blade reusableClass IIa
Orthopaedic bone staple non-adjustableOrthopaedic bone staple non-adjustableClass IIb
Orthopaedic bone washer non-sterileOrthopaedic bone washer non-sterileClass IIb
Internal orthopaedic fixation system cerclage wire/cable sterileInternal orthopaedic fixation system cerclage wire/cable sterileClass IIb
Frame/rail/pole device holderFrame/rail/pole device holderClass IIa
Surgical instrument handle gripSurgical instrument handle gripClass IIa
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIb
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIb
Surgical staple loading unit non-cuttingSurgical staple loading unit non-cuttingClass IIb
Arthroscopic irrigation/insufflation systemArthroscopic irrigation/insufflation systemClass IIa
Arthroscopic irrigation/insufflation systemArthroscopic irrigation/insufflation systemClass IIa
Surgical saw blade sagittal single-useSurgical saw blade sagittal single-useClass IIa
Surgical saw blade sagittal single-useSurgical saw blade sagittal single-useClass IIa
Surgical saw blade reciprocating single-useSurgical saw blade reciprocating single-useClass IIa
Surgical saw blade reciprocating single-useSurgical saw blade reciprocating single-useClass IIa
Surgical irrigation tubing set single-useSurgical irrigation tubing set single-useClass IIa
Surgical irrigation tubing set single-useSurgical irrigation tubing set single-useClass IIa
Orthopaedic bone screw non-bioabsorbable non-sterileOrthopaedic bone screw non-bioabsorbable non-sterileClass IIb
Suturing unit single-useSuturing unit single-useClass IIb
Partial shoulder prosthesisPartial shoulder prosthesisClass IIb
Arthroscopic surgical procedure kit non-medicated single-useArthroscopic surgical procedure kit non-medicated single-useClass IIb
Arthroscopic surgical procedure kit non-medicated single-useArthroscopic surgical procedure kit non-medicated single-useClass IIa
Tendon/ligament bone anchor non-bioabsorbableTendon/ligament bone anchor non-bioabsorbableClass IIa
Tendon/ligament bone anchor non-bioabsorbableTendon/ligament bone anchor non-bioabsorbableClass IIb
Decontamination floor mat single-useDecontamination floor mat single-useClass IIa
Foot-switch electricalFoot-switch electricalClass IIb
Foot-switch electricalFoot-switch electricalClass IIa
Endoscopic electrosurgical handpiece/electrode monopolar single-useEndoscopic electrosurgical handpiece/electrode monopolar single-useClass IIb
Surgical torque wrench reusableSurgical torque wrench reusableClass IIa
Endoscope sheath reusableEndoscope sheath reusableClass IIa
Rigid optical laparoscopeRigid optical laparoscopeClass IIa
Rigid endoscope obturatorRigid endoscope obturatorClass IIa
Endoscope video cameraEndoscope video cameraClass IIa
Arthroscopic shaver system blade single-useArthroscopic shaver system blade single-useClass IIa
Rigid arthroscope reusableRigid arthroscope reusableClass IIa
Orthopaedic bone screw non-bioabsorbable non-sterileOrthopaedic bone screw non-bioabsorbable non-sterileClass IIb
Surgical staple loading unit non-cuttingSurgical staple loading unit non-cuttingClass IIb
Orthopaedic bone washer sterileOrthopaedic bone washer sterileClass IIb
Arthroscopic shaver system handpiece electrically-poweredArthroscopic shaver system handpiece electrically-poweredClass IIa
Bone-coring punch reusableBone-coring punch reusableClass IIa
Orthopaedic trocar blade reusableOrthopaedic trocar blade reusableClass IIa
Orthopaedic surgical distractor internalOrthopaedic surgical distractor internalClass IIa
Suturing unit single-useSuturing unit single-useClass IIa
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Scalpel handle reusableScalpel handle reusableClass IIa
Scalpel handle reusableScalpel handle reusableClass I
Medical equipment drape single-useMedical equipment drape single-useClass IIa
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass IIa
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass IIa
Orthopaedic osteotomeOrthopaedic osteotomeClass I
Orthopaedic osteotomeOrthopaedic osteotomeClass IIa
Orthopaedic osteotomeOrthopaedic osteotomeClass IIa
Orthopaedic osteotomeOrthopaedic osteotomeClass IIa
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass IIa
Bone trephineBone trephineClass IIa
Bone trephineBone trephineClass I
Bone tap reusableBone tap reusableClass IIa
Bone tap reusableBone tap reusableClass IIa
Bone tap reusableBone tap reusableClass I
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass IIa
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass I
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Surgical depth gauge reusableSurgical depth gauge reusableClass IIa
Surgical depth gauge reusableSurgical depth gauge reusableClass I
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIa
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIa
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIa
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass I
Orthopaedic implant impactorOrthopaedic implant impactorClass IIa
Orthopaedic implant impactorOrthopaedic implant impactorClass I
Orthopaedic implant impactorOrthopaedic implant impactorClass IIa
Orthopaedic bone screw starter/notcherOrthopaedic bone screw starter/notcherClass IIa
Orthopaedic bone screw starter/notcherOrthopaedic bone screw starter/notcherClass IIa
Orthopaedic bone screw starter/notcherOrthopaedic bone screw starter/notcherClass I
Orthopaedic implant driverOrthopaedic implant driverClass IIa
Orthopaedic implant driverOrthopaedic implant driverClass I
Surgical tamp reusableSurgical tamp reusableClass IIa
Surgical tamp reusableSurgical tamp reusableClass I
Bone hookBone hookClass IIa
Bone hookBone hookClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass IIa
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Rigid arthroscope reusableRigid arthroscope reusableClass I
Bone approximation clampBone approximation clampClass IIa
Bone approximation clampBone approximation clampClass I
Bone lever/elevator reusableBone lever/elevator reusableClass IIa
Bone lever/elevator reusableBone lever/elevator reusableClass IIa
Bone lever/elevator reusableBone lever/elevator reusableClass I
Surgical drill guide reusableSurgical drill guide reusableClass IIa
Surgical drill guide reusableSurgical drill guide reusableClass IIa
Medullary canal orthopaedic reamer flexibleMedullary canal orthopaedic reamer flexibleClass IIa
Medullary canal orthopaedic reamer flexibleMedullary canal orthopaedic reamer flexibleClass IIa
Medullary canal orthopaedic reamer flexibleMedullary canal orthopaedic reamer flexibleClass IIa
Tendon stripperTendon stripperClass IIa
Tendon stripperTendon stripperClass IIa
Tendon stripperTendon stripperClass I
Bone file/rasp manual reusableBone file/rasp manual reusableClass IIa
Bone file/rasp manual reusableBone file/rasp manual reusableClass I
Orthopaedic bone wireOrthopaedic bone wireClass IIa
Orthopaedic bone wireOrthopaedic bone wireClass IIa
Rigid endoscope obturatorRigid endoscope obturatorClass I
Orthopaedic casting standOrthopaedic casting standClass IIa
Orthopaedic casting standOrthopaedic casting standClass I
Arthroscopic probeArthroscopic probeClass I
Endoscope video cameraEndoscope video cameraClass I
Arthroscopic access cannula single-useArthroscopic access cannula single-useClass I
Arthroscopic access cannula single-useArthroscopic access cannula single-useClass IIa
Arthroscopic obturatorArthroscopic obturatorClass I
Surgical implant template single-useSurgical implant template single-useClass IIa
Surgical implant template single-useSurgical implant template single-useClass I
Cannulated surgical drill bit single-use sterileCannulated surgical drill bit single-use sterileClass IIa
Cannulated surgical drill bit single-use sterileCannulated surgical drill bit single-use sterileClass IIa
Bone-resection orthopaedic reamer single-useBone-resection orthopaedic reamer single-useClass IIa
Bone-resection orthopaedic reamer single-useBone-resection orthopaedic reamer single-useClass IIa
Bone-resection orthopaedic reamer single-useBone-resection orthopaedic reamer single-useClass IIa
Osteotomy guide reusableOsteotomy guide reusableClass I
Osteotomy guide reusableOsteotomy guide reusableClass IIa
Arthroscopic access cannula seal single-useArthroscopic access cannula seal single-useClass IIa
Arthroscopic access cannula seal single-useArthroscopic access cannula seal single-useClass IIa
Wire/ligature passer single-useWire/ligature passer single-useClass IIa
Wire/ligature passer single-useWire/ligature passer single-useClass IIa
Instrument tray reusableInstrument tray reusableClass I
Dressing/utility forceps scissors-like reusableDressing/utility forceps scissors-like reusableClass I
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass IIa
Sterilization/disinfection container reusableSterilization/disinfection container reusableClass I
Polyolefin suture multifilamentPolyolefin suture multifilamentClass IIb
Bone awl reusableBone awl reusableClass I
Suture cutter reusableSuture cutter reusableClass I
Surgical countersink reusableSurgical countersink reusableClass I
Bone curette reusableBone curette reusableClass I
Wire cutterWire cutterClass I
Surgical instrument guard reusableSurgical instrument guard reusableClass I
Adhesive bandageAdhesive bandageClass IIa
Rigid endoscopic tissue manipulation forceps reusableRigid endoscopic tissue manipulation forceps reusableClass I
Chisel/osteotome blade handleChisel/osteotome blade handleClass I
Orthopaedic cerclage applierOrthopaedic cerclage applierClass I
Body aspiration needle single-useBody aspiration needle single-useClass IIa
Arthroscopic irrigation/insufflation systemArthroscopic irrigation/insufflation systemClass I
Orthopaedic broachOrthopaedic broachClass IIa
X-ray film magnifying glassX-ray film magnifying glassClass IIa
Orthopaedic operating table topOrthopaedic operating table topClass I
Manual scalpel blade single-useManual scalpel blade single-useClass IIa
Crown surgical drill bit reusableCrown surgical drill bit reusableClass IIa
General-purpose surgical scissors reusableGeneral-purpose surgical scissors reusableClass I
Endoscopic-access dilator single-useEndoscopic-access dilator single-useClass IIa
General-purpose surgical spatulaGeneral-purpose surgical spatulaClass I
Electromechanical device/system transport trolleyElectromechanical device/system transport trolleyClass I
Surgical finger guardSurgical finger guardClass IIa
Surgical instrument/implant rackSurgical instrument/implant rackClass I
General internal orthopaedic fixation system implantation kitGeneral internal orthopaedic fixation system implantation kitClass IIa
Manual orthopaedic bender reusableManual orthopaedic bender reusableClass I
Medical ruler reusableMedical ruler reusableClass IIa
Limb/torso/head restraint single-useLimb/torso/head restraint single-useClass I
Suture knot pusher reusableSuture knot pusher reusableClass I
Surgical instrument handle torque-limitingSurgical instrument handle torque-limitingClass I
Surgical instrument torque limiterSurgical instrument torque limiterClass I
Surgical instrument/implant depth limiterSurgical instrument/implant depth limiterClass I
Orthopaedic fixation implant alignment toolOrthopaedic fixation implant alignment toolClass I
Orthopaedic knee/leg holder linerOrthopaedic knee/leg holder linerClass IIa
Tendon/ligament graft preparation stationTendon/ligament graft preparation stationClass I
Surgical drill guide single-useSurgical drill guide single-useClass I
Patella prosthesis trialPatella prosthesis trialClass IIa
Humeral head prosthesis trial reusableHumeral head prosthesis trial reusableClass IIa
Surgical depth gauge single-useSurgical depth gauge single-useClass IIa
Orthopaedic prosthesis implantation instrument single-useOrthopaedic prosthesis implantation instrument single-useClass IIa
Knee arthroplasty force sensor balance kitKnee arthroplasty force sensor balance kitClass I
Orthopaedic implant/instrument assembling deviceOrthopaedic implant/instrument assembling deviceClass I
Bone access cannulaBone access cannulaClass IIa
Reverse shoulder head prosthesis trialReverse shoulder head prosthesis trialClass IIa
Shoulder glenoid fossa prosthesis trialShoulder glenoid fossa prosthesis trialClass IIa
Humeral body prosthesis trialHumeral body prosthesis trialClass IIa
Humeral stem prosthesis trial reusableHumeral stem prosthesis trial reusableClass IIa
Reverse shoulder cup prosthesis trial reusableReverse shoulder cup prosthesis trial reusableClass IIa
Humeral head spacer prosthesis trialHumeral head spacer prosthesis trialClass IIa
Shoulder reverse/standard adaptor prosthesis trialShoulder reverse/standard adaptor prosthesis trialClass IIa
Suturing needle single-useSuturing needle single-useClass IIa
Surgical implant/trial-implant/sizer holder single-useSurgical implant/trial-implant/sizer holder single-useClass I
Cannulated surgical drill guiding pinCannulated surgical drill guiding pinClass IIa
Arthroscopic access cannula reusableArthroscopic access cannula reusableClass I
Orthopaedic osteotome blade single-useOrthopaedic osteotome blade single-useClass IIa
Low-pressure tubing connector single-use sterileLow-pressure tubing connector single-use sterileClass IIa
Cannulated surgical drill bit single-use non-sterileCannulated surgical drill bit single-use non-sterileClass IIa
Orthopaedic implant inserter/extractor single-useOrthopaedic implant inserter/extractor single-useClass IIa
Surgical implant handling forcepsSurgical implant handling forcepsClass I
Glenoid defect sizerGlenoid defect sizerClass IIa
Reverse bone-resection orthopaedic reamerReverse bone-resection orthopaedic reamerClass IIa
Tendon/ligament graft preparation stationTendon/ligament graft preparation stationClass IIa
Internal orthopaedic fixation system plate/screw non-bioabsorbable non-sterileInternal orthopaedic fixation system plate/screw non-bioabsorbable non-sterileClass IIb
Orthopaedic bone screw bioabsorbableOrthopaedic bone screw bioabsorbableClass III
Orthopaedic bur reusableOrthopaedic bur reusableClass IIa
Endoscopic electrosurgical electrode bipolar single-useEndoscopic electrosurgical electrode bipolar single-useClass IIb
Orthopaedic bone pin bioabsorbableOrthopaedic bone pin bioabsorbableClass III
Bone trephineBone trephineClass IIa
Surgical depth gauge reusableSurgical depth gauge reusableClass IIa
Surgical drill guide reusableSurgical drill guide reusableClass IIa
Surgical drill guide reusableSurgical drill guide reusableClass I
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass I
Dressing/utility forceps tweezers-like reusableDressing/utility forceps tweezers-like reusableClass I
Surgical flat-nosed pliersSurgical flat-nosed pliersClass I
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass IIa
Cannulated surgical drill bit single-use sterileCannulated surgical drill bit single-use sterileClass IIa
Endoscope sheath reusableEndoscope sheath reusableClass I
Tendon/ligament graft preparation station baseTendon/ligament graft preparation station baseClass IIa
Tendon/ligament graft preparation station baseTendon/ligament graft preparation station baseClass I
Tendon/ligament graft preparation station postTendon/ligament graft preparation station postClass IIa
Leg procedure positionerLeg procedure positionerClass I
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass IIa
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass I
Bone tunnel plug non-cannulatedBone tunnel plug non-cannulatedClass IIa
Bone tunnel plug non-cannulatedBone tunnel plug non-cannulatedClass I
Arm procedure positioner reusableArm procedure positioner reusableClass IIa
Endoscopic-access dilator reusableEndoscopic-access dilator reusableClass IIa
Orthopaedic osteotome blade reusableOrthopaedic osteotome blade reusableClass IIa
Orthopaedic osteotome blade reusableOrthopaedic osteotome blade reusableClass IIa
Orthopaedic osteotome blade reusableOrthopaedic osteotome blade reusableClass I
Bone/joint surgical power tool motorized handpiece/set electric reusableBone/joint surgical power tool motorized handpiece/set electric reusableClass IIa
Orthopaedic bur single-useOrthopaedic bur single-useClass IIa
Soft-tissue surgical hook reusableSoft-tissue surgical hook reusableClass IIa
Sawing power tool attachment reciprocatingSawing power tool attachment reciprocatingClass IIa
Sawing power tool attachment reciprocatingSawing power tool attachment reciprocatingClass IIa
Orthopaedic surgical procedure kit non-medicated single-useOrthopaedic surgical procedure kit non-medicated single-useClass IIa
Orthopaedic graft inserterOrthopaedic graft inserterClass IIa
Orthopaedic graft inserterOrthopaedic graft inserterClass I
Orthopaedic graft tensioner reusableOrthopaedic graft tensioner reusableClass IIa
Orthopaedic graft tensioner reusableOrthopaedic graft tensioner reusableClass I
Orthopaedic graft guideOrthopaedic graft guideClass IIa
Orthopaedic graft guideOrthopaedic graft guideClass IIa
Orthopaedic reamer guideOrthopaedic reamer guideClass IIa
Orthopaedic reamer guideOrthopaedic reamer guideClass I
Bone-resection orthopaedic reamer reusableBone-resection orthopaedic reamer reusableClass IIa
Bone-resection orthopaedic reamer reusableBone-resection orthopaedic reamer reusableClass IIa
Suture knot pusher single-useSuture knot pusher single-useClass IIa
Suture knot pusher single-useSuture knot pusher single-useClass IIa
Hand-held surgical retractor reusableHand-held surgical retractor reusableClass IIa
Orthopaedic implantation sleeve reusableOrthopaedic implantation sleeve reusableClass IIa
Bone tap single-use sterileBone tap single-use sterileClass IIa
Bone tap single-use sterileBone tap single-use sterileClass IIa
Joint prosthesis implantation kit reusableJoint prosthesis implantation kit reusableClass I
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa
Drilling power tool attachment basicDrilling power tool attachment basicClass IIa
Arthroscopic surgical procedure kit non-medicated single-useArthroscopic surgical procedure kit non-medicated single-useClass IIa
Arthroscopic surgical procedure kit non-medicated single-useArthroscopic surgical procedure kit non-medicated single-useClass IIa
Arthroscopic surgical procedure kit non-medicated single-useArthroscopic surgical procedure kit non-medicated single-useClass IIa
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass I
Orthopaedic surgical procedure kit non-medicated single-useOrthopaedic surgical procedure kit non-medicated single-useClass IIa
Arthroscopic shaver system electrically-poweredArthroscopic shaver system electrically-poweredClass IIa
Orthopaedic bone wireOrthopaedic bone wireClass IIa
Suturing unit single-useSuturing unit single-useClass IIa
Total reverse shoulder prosthesisTotal reverse shoulder prosthesisClass III
Arthroscopic surgical procedure kit non-medicated single-useArthroscopic surgical procedure kit non-medicated single-useClass IIa
Arthroscopic shaver system electrically-poweredArthroscopic shaver system electrically-poweredClass IIa
Internal orthopaedic fixation system plate/screw non-bioabsorbable sterileInternal orthopaedic fixation system plate/screw non-bioabsorbable sterileClass IIb
Internal orthopaedic fixation system plate/screw non-bioabsorbable sterileInternal orthopaedic fixation system plate/screw non-bioabsorbable sterileClass IIb