Manufacturer's Devices - Exactech Inc.

Address:




2320 NW 66 Ct



Gainesville FL

32653

United States


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

Prospect House Fishing Line Road



Redditch

Worcestershire B97 6EW

England United Kingdom




Code/Term Type
Knee femur stem prosthesisKnee femur stem prosthesisClass IIb
Knee arthroplasty wedgeKnee arthroplasty wedgeClass IIb
Internal orthopaedic fixation system plate/screw non-bioabsorbable non-sterileInternal orthopaedic fixation system plate/screw non-bioabsorbable non-sterileClass IIb
Mobile-bearing total ankle prosthesisMobile-bearing total ankle prosthesisClass IIb
Uncoated knee femur prosthesis metallicUncoated knee femur prosthesis metallicClass III
Uncoated knee tibia prosthesis metallicUncoated knee tibia prosthesis metallicClass III
Mobile-bearing total knee prosthesisMobile-bearing total knee prosthesisClass III
Partial shoulder prosthesisPartial shoulder prosthesisClass III
Coated knee femur prosthesisCoated knee femur prosthesisClass III
Uncoated shoulder humeral stem prosthesisUncoated shoulder humeral stem prosthesisClass III
Polyethylene patella prosthesisPolyethylene patella prosthesisClass III
Shoulder glenoid fossa prosthesis prefabricatedShoulder glenoid fossa prosthesis prefabricatedClass III
Knee femur stem prosthesisKnee femur stem prosthesisClass III
Stem-fixed humeral head prosthesisStem-fixed humeral head prosthesisClass III
Resurfacing humeral head prosthesisResurfacing humeral head prosthesisClass III
Press-fit shoulder humeral stem prosthesisPress-fit shoulder humeral stem prosthesisClass III
Reverse shoulder prosthesis base plateReverse shoulder prosthesis base plateClass III
Polyethylene reverse shoulder prosthesis cupPolyethylene reverse shoulder prosthesis cupClass III
Reverse shoulder prosthesis headReverse shoulder prosthesis headClass III
Shoulder prosthesis screwShoulder prosthesis screwClass III
Tibial insertTibial insertClass III
Reverse shoulder prosthesis bodyReverse shoulder prosthesis bodyClass III
Shoulder humeral body prosthesisShoulder humeral body prosthesisClass III
Resurfacing shoulder humeral stem prosthesisResurfacing shoulder humeral stem prosthesisClass III
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass IIa
Orthopaedic osteotomeOrthopaedic osteotomeClass IIa
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass IIa
Bone trephineBone trephineClass IIa
Surgical drill chuckSurgical drill chuckClass IIa
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Surgical depth gauge reusableSurgical depth gauge reusableClass IIa
Acetabular orthopaedic reamerAcetabular orthopaedic reamerClass IIa
Surgical tamp reusableSurgical tamp reusableClass IIa
Surgical screwdriver reusableSurgical screwdriver reusableClass IIa
Surgical drill guide reusableSurgical drill guide reusableClass IIa
Medullary canal orthopaedic reamer flexibleMedullary canal orthopaedic reamer flexibleClass IIa
Reverse shoulder cup prosthesis trial reusableReverse shoulder cup prosthesis trial reusableClass IIa
Orthopaedic broachOrthopaedic broachClass IIa
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa
Orthopaedic reamer guideOrthopaedic reamer guideClass IIa
Bone-resection orthopaedic reamer reusableBone-resection orthopaedic reamer reusableClass IIa
Medullary canal orthopaedic reamer rigidMedullary canal orthopaedic reamer rigidClass IIa
Surgical saw blade reciprocating single-useSurgical saw blade reciprocating single-useClass IIa
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass IIa
Surgical instrument handle torque-limitingSurgical instrument handle torque-limitingClass IIa
Acetabulum prosthesis trial prefabricated reusableAcetabulum prosthesis trial prefabricated reusableClass IIa
Knee femur prosthesis trial reusableKnee femur prosthesis trial reusableClass IIa
Humeral head prosthesis trial reusableHumeral head prosthesis trial reusableClass IIa
Glenoid orthopaedic reamerGlenoid orthopaedic reamerClass 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
Ankle prosthesis trialAnkle prosthesis trialClass IIa
Intraoperative bone pin/screw sterileIntraoperative bone pin/screw sterileClass IIa
Intraoperative bone pin/screw non-sterileIntraoperative bone pin/screw non-sterileClass IIa
Hazardous chemical decontamination agent home-useHazardous chemical decontamination agent home-useClass IIa
Patella prosthesis trialPatella prosthesis trialClass IIa
Femoral head prosthesis trialFemoral head prosthesis trialClass IIa
Femoral stem prosthesis trialFemoral stem prosthesis trialClass IIa
Knee tibia prosthesis trial reusableKnee tibia prosthesis trial reusableClass IIa
Stem-fixed humeral head prosthesisStem-fixed humeral head prosthesisClass IIb
Coated shoulder humeral stem prosthesisCoated shoulder humeral stem prosthesisClass III
Instrument tray reusableInstrument tray reusableClass I
Orthopaedic osteotomeOrthopaedic osteotomeClass I
Sterilization/disinfection container reusableSterilization/disinfection container reusableClass I
Bone curette reusableBone curette reusableClass I
Surgical depth gauge reusableSurgical depth gauge reusableClass I
Orthopaedic implant impactorOrthopaedic implant impactorClass I
Orthopaedic implant driverOrthopaedic implant driverClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Orthopaedic broachOrthopaedic broachClass I
Joint prosthesis implantation kit reusableJoint prosthesis implantation kit reusableClass I
Orthopaedic reamer guideOrthopaedic reamer guideClass I
Bone-resection orthopaedic reamer reusableBone-resection orthopaedic reamer reusableClass I
Surgical implant template reusableSurgical implant template reusableClass I
Orthopaedic instrument surgical connectorOrthopaedic instrument surgical connectorClass 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
Orthopaedic implant/instrument assembling deviceOrthopaedic implant/instrument assembling deviceClass I
Ankle prosthesis trialAnkle prosthesis trialClass I
Instrument tray reusableInstrument tray reusableClass I
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass I
Surgical implant template reusableSurgical implant template reusableClass I
Humeral stem extension prosthesisHumeral stem extension prosthesisClass III
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass I
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass I
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass I
Surgical tamp reusableSurgical tamp reusableClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
Bone file/rasp manual reusableBone file/rasp manual reusableClass I
Hand-held surgical retractor reusableHand-held surgical retractor reusableClass I
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass I
Orthopaedic fixation implant alignment toolOrthopaedic fixation implant alignment toolClass I
Osteotomy guide reusableOsteotomy guide reusableClass I
Intraoperative bone pin/screw non-sterileIntraoperative bone pin/screw non-sterileClass I
Orthopaedic instrument extractorOrthopaedic instrument extractorClass I