Manufacturer's Devices - Howmedica Osteonics Corp.

Address:




325 Corporate Drive



Mahwah

New Jersey 07430

United States


Authorised Representative/ UK Responsible Person
Name: Stryker UK Ltd
Address:

Stryker House Hambridge Road



Newbury

Berkshire RG14 5AW

England United Kingdom




Code/Term Type
Orthopaedic cement antimicrobialOrthopaedic cement antimicrobialClass III
Polyethylene acetabulum prosthesisPolyethylene acetabulum prosthesisClass III
Body femoral/tibial extension stem uncoatedBody femoral/tibial extension stem uncoated
Joint prosthesis implantation kit single-useJoint prosthesis implantation kit single-use
Body femoral/tibial extension stem coatedBody femoral/tibial extension stem coated
Orthopaedic bone screw non-bioabsorbable sterileOrthopaedic bone screw non-bioabsorbable sterile
Non-constrained polyethylene acetabular linerNon-constrained polyethylene acetabular linerClass III
Uncoated knee tibia prosthesis metallicUncoated knee tibia prosthesis metallic
Orthopaedic prosthesis implantation positioning instrument reusableNon-constrained polyethylene acetabular liner Conformity Assessment Certificate ExpiredClass III
Bone awl reusableOrthopaedic prosthesis implantation positioning instrument reusableClass IIa
Fluted surgical drill bit reusableBone awl reusableClass IIa
Surgical drill guide reusableFluted surgical drill bit reusableClass IIa
Orthopaedic cement dispenserSurgical drill guide reusableClass IIa
Orthopaedic surgical procedure kit non-medicated single-useOrthopaedic cement dispenserClass IIa
Surgical implant template reusableOrthopaedic surgical procedure kit non-medicated single-useClass IIa
Orthopaedic fixation implant alignment toolSurgical implant template reusableClass IIa
Patella prosthesis trialOrthopaedic fixation implant alignment toolClass IIa
Knee femur prosthesis trial reusablePatella prosthesis trialClass IIa
Orthopaedic prosthesis implantation positioning instrument single-useKnee femur prosthesis trial reusableClass IIa
Hand-held surgical retractor single-useOrthopaedic prosthesis implantation positioning instrument single-useClass IIa
Polyethylene patella prosthesisHand-held surgical retractor single-useClass IIa
Uncoated knee femur prosthesis metallicPolyethylene patella prosthesisClass IIa
Uncoated knee tibia prosthesis polyethyleneUncoated knee femur prosthesis metallicClass III
Coated knee femur prosthesisUncoated knee tibia prosthesis polyethyleneClass IIb
Metal-backed patella prosthesisCoated knee femur prosthesisClass III
Coated knee tibia prosthesisMetal-backed patella prosthesisClass III
Knee femur stem prosthesisCoated knee tibia prosthesisClass III
Knee arthroplasty wedgeKnee femur stem prosthesisClass III
Uncoated hip femur prosthesis modularKnee arthroplasty wedgeClass III
Orthopaedic osteotomeCoated knee femur prosthesis Conformity Assessment Certificate ExpiredClass III
Orthopaedic implant inserter/extractor reusableUncoated knee femur prosthesis metallic Conformity Assessment Certificate ExpiredClass III
Acetabular orthopaedic reamerUncoated knee tibia prosthesis polyethylene Conformity Assessment Certificate ExpiredClass IIb
Bone file/rasp manual reusableMetal-backed patella prosthesis Conformity Assessment Certificate ExpiredClass IIb
Orthopaedic broachUncoated hip femur prosthesis modularClass III
Surgical power tool system handpiece reaming pneumaticOrthopaedic osteotomeClass III
Bone-resection orthopaedic reamer reusableOrthopaedic implant inserter/extractor reusableClass III
Medullary canal orthopaedic reamer rigidAcetabular orthopaedic reamerClass III
Femoral head prosthesis trialBone file/rasp manual reusableClass III
Acetabulum prosthesis trial prefabricated reusableOrthopaedic broach
Femoral stem prosthesis trialSurgical power tool system handpiece reaming pneumaticClass IIb
Unicondylar knee prosthesisBone-resection orthopaedic reamer reusableClass IIa
Ceramic femoral head prosthesisMedullary canal orthopaedic reamer rigidClass IIa
Femoral head/stem prosthesis adaptorFemoral head prosthesis trialClass IIa
Patellofemoral joint prosthesisAcetabulum prosthesis trial prefabricated reusableClass IIa
Orthopaedic chiselFemoral stem prosthesis trialClass IIa
Surgical malletUnicondylar knee prosthesisClass IIa
Surgical depth gauge reusableCeramic femoral head prosthesisClass IIa
Orthopaedic implant driverFemoral head/stem prosthesis adaptorClass IIa
Manual goniometerPatellofemoral joint prosthesisClass IIa
Surgical screwdriver reusableOrthopaedic chiselClass IIa
Bone lever/elevator reusableSurgical malletClass IIa
Medical ruler reusableSurgical depth gauge reusableClass IIa
Orthopaedic reamer guideOrthopaedic implant driverClass IIa
Self-retaining surgical retractor reusableManual goniometerClass IIb
Bone holding forcepsSurgical screwdriver reusableClass III
Orthopaedic implant aiming armBone lever/elevator reusableClass III
Surgical instrument handle non-torque-limitingMedical ruler reusableClass III
Orthopaedic implantation sleeve reusableOrthopaedic reamer guideClass III
Knee tibia prosthesis trial reusableSelf-retaining surgical retractor reusableClass III
Orthopaedic implant impactor reusableBone holding forcepsClass III
Polysulfide dental impression materialOrthopaedic implant aiming armClass III
Surgical torque wrench reusableSurgical instrument handle non-torque-limitingClass I
Surgical saw blade reciprocating reusableOrthopaedic implantation sleeve reusableClass I
Press-fit hip femur prosthesis modularKnee tibia prosthesis trial reusableClass I
Instrument tray reusableOrthopaedic implant impactor reusableClass I
Orthopaedic bone pin non-bioabsorbablePolysulfide dental impression materialClass I
Coated femoral stem prosthesis modularSurgical torque wrench reusableClass I
Surgical gougeSurgical saw blade reciprocating reusableClass I
Orthopaedic implant-instrument extension adaptor reusablePress-fit hip femur prosthesis modularClass I
Ceramic acetabular linerInstrument tray reusableClass I
Metallic femoral head prosthesisOrthopaedic bone pin non-bioabsorbableClass I
Acetabular shellCoated femoral stem prosthesis modularClass I
Acetabulum prosthesis hole plugSurgical gougeClass I
Metallic acetabulum prosthesisOrthopaedic implant-instrument extension adaptor reusableClass I
Press-fit femoral stem prosthesisCeramic acetabular linerClass I
Polymer orthopaedic cement restrictor non-bioabsorbableMetallic femoral head prosthesisClass I
Rotating hinged total knee prosthesisAcetabular shellClass I
Orthopaedic cement non-antimicrobialAcetabulum prosthesis hole plugClass I
Bipolar femoral head outer component hemiarthroplastyMetallic acetabulum prosthesisClass I
Uncoated hip femur prosthesis one-pieceAcetabular shell Conformity Assessment Certificate ExpiredClass I
Orthopaedic bone wirePress-fit femoral stem prosthesisClass I
Internal orthopaedic fixation system plate/screw non-bioabsorbable sterilePress-fit femoral stem prosthesis Conformity Assessment Certificate ExpiredClass I
Tibial insertPolymer orthopaedic cement restrictor non-bioabsorbableClass I
Surgical power tool adaptorRotating hinged total knee prosthesisClass I
Coated hip femur prosthesis modularOrthopaedic cement non-antimicrobialClass I
Combination-material acetabulum prosthesisBipolar femoral head outer component hemiarthroplastyClass I
Combination-material acetabulum prosthesisUncoated hip femur prosthesis one-pieceClass I
Combination-material acetabulum prosthesisOrthopaedic bone wireClass I
Combination-material acetabulum prosthesisInternal orthopaedic fixation system plate/screw non-bioabsorbable sterileClass I
Combination-material acetabulum prosthesisTibial insertClass I
Combination-material acetabulum prosthesisSurgical power tool adaptorClass I
Combination-material acetabulum prosthesisCoated hip femur prosthesis modularClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass I
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIb
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass IIa
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate Expired
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate Expired
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III
Combination-material acetabulum prosthesisCombination-material acetabulum prosthesis Conformity Assessment Certificate ExpiredClass III