Manufacturer's Devices - Ascension Orthopedics Inc

Address:




11101 Metric Boulevard



Austin

Texas 78758

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
Fixed-bearing total ankle prosthesisFixed-bearing total ankle prosthesisClass IIb
Carpal trapezium prosthesisCarpal trapezium prosthesisClass IIb
Metacarpophalangeal joint prosthesis one-pieceMetacarpophalangeal joint prosthesis one-pieceClass IIb
Metacarpal prosthesisMetacarpal prosthesisClass IIb
Orthopaedic bone screw non-bioabsorbable non-sterileOrthopaedic bone screw non-bioabsorbable non-sterileClass IIb
Proximal interphalangeal joint prosthesis modularProximal interphalangeal joint prosthesis modularClass IIb
Metacarpophalangeal joint prosthesis modularMetacarpophalangeal joint prosthesis modularClass IIb
Surgical soft-tissue manipulation forceps alligator reusableSurgical soft-tissue manipulation forceps alligator reusableClass III
External orthopaedic fixation system reusableExternal orthopaedic fixation system reusableClass III
Shoulder glenoid fossa prosthesis prefabricatedShoulder glenoid fossa prosthesis prefabricatedClass III
Coated shoulder humeral stem prosthesisCoated shoulder humeral stem prosthesisClass III
Orthopaedic bone screw non-bioabsorbable sterileOrthopaedic bone screw non-bioabsorbable sterileClass III
Stem-fixed humeral head prosthesisStem-fixed humeral head 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
Reverse shoulder prosthesis bodyReverse shoulder prosthesis bodyClass III
Proximal interphalangeal joint prosthesis one-pieceProximal interphalangeal joint prosthesis one-pieceClass IIb
Carpal lunate prosthesisCarpal lunate prosthesisClass IIb
Bone cutterBone cutterClass IIa
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Instrument tray reusableInstrument tray reusableClass IIa
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass IIa
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass IIa
Bone awl reusableBone awl reusableClass IIa
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Surgical depth gauge reusableSurgical depth gauge reusableClass IIa
Orthopaedic implant impactorOrthopaedic implant impactorClass IIa
Surgical screwdriver reusableSurgical screwdriver reusableClass IIa
Surgical drill guide reusableSurgical drill guide reusableClass IIa
Orthopaedic bone wireOrthopaedic bone wireClass IIa
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa
Joint prosthesis implantation kit reusableJoint prosthesis implantation kit reusableClass IIa
Orthopaedic reamer guideOrthopaedic reamer guideClass IIa
Bone-resection orthopaedic reamer reusableBone-resection orthopaedic reamer reusableClass IIa
ENT stereotactic surgery systemENT stereotactic surgery systemClass IIa
Hand-held surgical retractor reusableHand-held surgical retractor reusableClass IIa
Orthopaedic cement compressorOrthopaedic cement compressorClass IIa
Bone nail guidewire reusableBone nail guidewire reusableClass IIa
Surgical implant/trial-implant/sizer holder reusableSurgical implant/trial-implant/sizer holder reusableClass IIa
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass IIa
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass IIa
Surgical instrument/implant depth limiterSurgical instrument/implant depth limiterClass IIa
Orthopaedic fixation implant alignment toolOrthopaedic fixation implant alignment toolClass IIa
Orthopaedic fixation implant alignment toolOrthopaedic fixation implant alignment toolClass IIa
Humeral head prosthesis trial reusableHumeral head prosthesis trial reusableClass IIa
Orthopaedic implant/instrument assembling deviceOrthopaedic implant/instrument assembling deviceClass 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
Reverse shoulder cup prosthesis trial reusableReverse shoulder cup prosthesis trial reusableClass IIa
Cannulated surgical drill bit single-use sterileCannulated surgical drill bit single-use sterileClass IIa
Ankle prosthesis trialAnkle prosthesis trialClass IIa
Osteotomy guide reusableOsteotomy guide reusableClass IIa
Intraoperative bone pin/screw non-sterileIntraoperative bone pin/screw non-sterileClass IIa
Intraoperative bone pin/screw non-sterileIntraoperative bone pin/screw non-sterileClass IIa
Orthopaedic instrument extractorOrthopaedic instrument extractorClass IIa
Cannulated surgical drill bit single-use non-sterileCannulated surgical drill bit single-use non-sterileClass IIa
Bone cutterBone cutterClass I
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass I
Instrument tray reusableInstrument tray reusableClass I
Orthopaedic osteotomeOrthopaedic osteotomeClass I
Sterilization/disinfection container reusableSterilization/disinfection container reusableClass I
Bone awl reusableBone awl reusableClass I
Surgical countersink reusableSurgical countersink reusableClass I
Bone tap reusableBone tap reusableClass I
Surgical malletSurgical malletClass I
Orthopaedic implant impactorOrthopaedic implant impactorClass I
Fixed-bearing total ankle prosthesisFixed-bearing total ankle prosthesisClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
Bone file/rasp manual reusableBone file/rasp manual reusableClass I
Orthopaedic broachOrthopaedic broachClass I
Surgical flat-nosed pliersSurgical flat-nosed pliersClass I
Joint prosthesis implantation kit reusableJoint prosthesis implantation kit reusableClass I
Orthopaedic reamer guideOrthopaedic reamer guideClass I
Bone nail guidewire reusableBone nail guidewire reusableClass I
Surgical implant template reusableSurgical implant template reusableClass I
Orthopaedic instrument surgical connectorOrthopaedic instrument surgical connectorClass I
Orthopaedic implant aiming armOrthopaedic implant aiming armClass I
Surgical implant/trial-implant/sizer holder reusableSurgical implant/trial-implant/sizer holder reusableClass I
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass I
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass I
Surgical instrument torque limiterSurgical instrument torque limiterClass I
Orthopaedic implant/instrument assembling deviceOrthopaedic implant/instrument assembling deviceClass I
Osteotomy guide reusableOsteotomy guide reusableClass I
Orthopaedic instrument extractorOrthopaedic instrument extractorClass I
Cannulated surgical drill bit single-use non-sterileCannulated surgical drill bit single-use non-sterileClass I
Bone-coring punch reusableBone-coring punch reusableClass I
Elbow radius prosthesisElbow radius prosthesisClass IIb
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Surgical implant template reusableSurgical implant template reusableClass IIa
Humeral stem prosthesis trial reusableHumeral stem prosthesis trial reusableClass IIa
Elbow radius prosthesis trialElbow radius prosthesis trialClass IIa
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass I
Bone-resection orthopaedic reamer reusableBone-resection orthopaedic reamer reusableClass I
Hand-held surgical retractor reusableHand-held surgical retractor reusableClass I
Bone-resection orthopaedic reamer reusableBone-resection orthopaedic reamer reusableClass IIa
Instrument tray reusableInstrument tray reusableClass I
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass I
Hand-held surgical retractor reusableHand-held surgical retractor reusableClass IIa
Carpometacarpal interpositional spacer prosthesis trialCarpometacarpal interpositional spacer prosthesis trialClass IIa
Orthopaedic bur reusableOrthopaedic bur reusableClass I
Stem-fixed humeral head prosthesisStem-fixed humeral head prosthesisClass III
Shoulder prosthesis screwShoulder prosthesis screwClass III
Shoulder humeral body prosthesisShoulder humeral body prosthesisClass III