Manufacturer's Devices - Zimmer Inc.

Address:

1800 West Center Street

Indiana

Warsaw 46580

United States

Authorised Representative/ UK Responsible Person
Name: Zimmer Biomet UK Limited
Address:

Stella Building Windmill Hill Business Park

Whitehill Way

Swindon

SN5 6NX

England United Kingdom

Code/Term		Type
Orthopaedic bone pin non-bioabsorbable	Orthopaedic bone pin non-bioabsorbable	Class IIa
Orthopaedic bone wire	Orthopaedic bone wire	Class IIa
General-purpose surgical spatula	General-purpose surgical spatula	Class IIa
Orthopaedic implant aiming/guiding block reusable	Orthopaedic implant aiming/guiding block reusable	Class IIa
Orthopaedic implant-instrument extension adaptor reusable	Orthopaedic implant-instrument extension adaptor reusable	Class IIa
Patella prosthesis trial	Patella prosthesis trial	Class IIa
Elbow humerus prosthesis trial	Elbow humerus prosthesis trial	Class IIa
Orthopaedic bone nut	Orthopaedic bone nut	Class IIa
Knee femur stem prosthesis	Knee femur stem prosthesis	Class IIb
Patellofemoral joint prosthesis	Patellofemoral joint prosthesis	Class IIb
Revision coated hip femur prosthesis	Revision coated hip femur prosthesis	Class IIb
Reverse shoulder prosthesis base plate	Reverse shoulder prosthesis base plate	Class III
Revision uncoated hip femur prosthesis	Revision uncoated hip femur prosthesis	Class III
Uncoated knee tibia prosthesis metallic	Uncoated knee tibia prosthesis metallic	Class III
Elbow radius prosthesis	Elbow radius prosthesis	Class IIb
Orthopaedic cement spacer	Orthopaedic cement spacer	Class IIb
External orthopaedic fixation system reusable	External orthopaedic fixation system reusable	Class IIb
Polymer orthopaedic cement restrictor non-bioabsorbable	Polymer orthopaedic cement restrictor non-bioabsorbable	Class IIb
Hinged total elbow prosthesis	Hinged total elbow prosthesis	Class IIb
External orthopaedic fixation system single-use sterile	External orthopaedic fixation system single-use sterile	Class IIb
Acetabulum prosthesis hole plug	Acetabulum prosthesis hole plug	Class IIb
Non-constrained polyethylene acetabular liner	Non-constrained polyethylene acetabular liner	Class IIb
Orthopaedic bone washer non-sterile	Orthopaedic bone washer non-sterile	Class IIb
Orthopaedic bone washer sterile	Orthopaedic bone washer sterile	Class IIb
Internal orthopaedic fixation system plate/screw non-bioabsorbable sterile	Internal orthopaedic fixation system plate/screw non-bioabsorbable sterile	Class IIb
Internal orthopaedic fixation system cerclage wire/cable sterile	Internal orthopaedic fixation system cerclage wire/cable sterile	Class IIb
Tibial insert	Tibial insert	Class IIb
Hip prosthesis socket pusher	Hip prosthesis socket pusher	Class IIb
Surgical screwdriver reusable	Surgical screwdriver reusable	Class IIb
Surgical depth gauge reusable	Surgical depth gauge reusable	Class III
Orthopaedic implant impactor reusable	Orthopaedic implant impactor reusable	Class I
Surgical drill guide reusable	Surgical drill guide reusable	Class I
Bone-resection orthopaedic reamer reusable	Bone-resection orthopaedic reamer reusable	Class I
Orthopaedic trocar blade reusable	Orthopaedic trocar blade reusable	Class I
Surgical instrument handle non-torque-limiting	Surgical instrument handle non-torque-limiting	Class I
Acetabulum prosthesis trial prefabricated reusable	Acetabulum prosthesis trial prefabricated reusable	Class I
Femoral stem prosthesis trial	Femoral stem prosthesis trial	Class I
Humeral head prosthesis trial reusable	Humeral head prosthesis trial reusable	Class I
Orthopaedic cement restrictor sizer	Orthopaedic cement restrictor sizer	Class I
Orthopaedic prosthesis implantation positioning instrument reusable	Orthopaedic prosthesis implantation positioning instrument reusable	Class I
Fluted surgical drill bit reusable	Fluted surgical drill bit reusable	Class I
Polyethylene patella prosthesis	Polyethylene patella prosthesis	Class I
Coated knee femur prosthesis	Coated knee femur prosthesis	Class I
Coated knee tibia prosthesis	Coated knee tibia prosthesis	Class I
Uncoated knee femur prosthesis metallic	Uncoated knee femur prosthesis metallic	Class III
Bone nail end-cap	Bone nail end-cap	Class IIa
Bone file/rasp manual reusable	Bone file/rasp manual reusable	Class III
Bipolar femoral head outer component hemiarthroplasty	Bipolar femoral head outer component hemiarthroplasty	Class III
Acetabular shell	Acetabular shell	Class III
Coated shoulder humeral stem prosthesis	Coated shoulder humeral stem prosthesis	Class III
Constrained polyethylene acetabular liner	Constrained polyethylene acetabular liner	Class III
Elbow ulna prosthesis trial	Elbow ulna prosthesis trial	Class III
Femoral stem centralizer	Femoral stem centralizer	Class III
External orthopaedic fixation system single-use	External orthopaedic fixation system single-use	Class I
Femoral head prosthesis trial	Femoral head prosthesis trial	Class IIb
Femur nail	Femur nail	Class IIa
Instrument tray reusable	Instrument tray reusable	Class I
Knee arthroplasty wedge	Knee arthroplasty wedge	Class IIb
Knee femur prosthesis trial reusable	Knee femur prosthesis trial reusable	Class III
Knee tibia prosthesis trial reusable	Knee tibia prosthesis trial reusable	Class IIa
Metallic acetabulum prosthesis	Metallic acetabulum prosthesis	Class IIa
Metallic femoral head prosthesis	Metallic femoral head prosthesis	Class III
Orthopaedic bone screw non-bioabsorbable sterile	Orthopaedic bone screw non-bioabsorbable sterile	Class III
Orthopaedic implant inserter/extractor reusable	Orthopaedic implant inserter/extractor reusable	Class III
Orthopaedic prosthesis implantation positioning instrument single-use	Orthopaedic prosthesis implantation positioning instrument single-use	Class IIa
Polyethylene acetabulum prosthesis	Polyethylene acetabulum prosthesis	Class IIb
Press-fit femoral stem prosthesis	Press-fit femoral stem prosthesis	Class IIb
Stem-fixed humeral head prosthesis	Stem-fixed humeral head prosthesis	Class IIa
Tibia nail	Tibia nail	Class IIa
Uncoated hip femur prosthesis one-piece	Uncoated hip femur prosthesis one-piece	Class IIb
Uncoated knee tibia prosthesis polyethylene	Uncoated knee tibia prosthesis polyethylene	Class IIa
Uncoated shoulder humeral stem prosthesis	Uncoated shoulder humeral stem prosthesis	Class I
Internal orthopaedic fixation system plate/screw non-bioabsorbable non-sterile	Internal orthopaedic fixation system plate/screw non-bioabsorbable non-sterile	Class IIb
Orthopaedic fixation plate non-bioabsorbable sterile	Orthopaedic fixation plate non-bioabsorbable sterile	Class IIa
Orthopaedic fixation plate non-bioabsorbable non-sterile	Orthopaedic fixation plate non-bioabsorbable non-sterile	Class IIa
Device sterilization/disinfection container reusable	Device sterilization/disinfection container reusable	Class III
Coated elbow humerus prosthesis	Coated elbow humerus prosthesis	Class III
Trabeculated shoulder humeral stem prosthesis	Tibial insert Conformity Assessment Certificate Expired	Class III
Shoulder glenoid fossa prosthesis prefabricated	Knee femur stem prosthesis Conformity Assessment Certificate Expired	Class III
Fixed-bearing total ankle prosthesis	Uncoated knee tibia prosthesis metallic Conformity Assessment Certificate Expired	Class IIb
Coated ankle tibia prosthesis	Uncoated knee femur prosthesis metallic Conformity Assessment Certificate Expired	Class IIb
Coated ankle talus prosthesis	Trabeculated shoulder humeral stem prosthesis	Class I
Uncoated unicondylar knee femur prosthesis	Shoulder glenoid fossa prosthesis prefabricated	Class I
Uncoated unicondylar knee tibia prosthesis metallic	Fixed-bearing total ankle prosthesis	Class IIa
Uncoated elbow humerus prosthesis	Coated ankle tibia prosthesis	Class III
Press-fit hip femur prosthesis modular	Coated ankle talus prosthesis	Class III
Unicondylar knee insert	Uncoated unicondylar knee femur prosthesis	Class III
Orthopaedic implant-instrument extension adaptor single-use	Uncoated unicondylar knee tibia prosthesis metallic	Class III
Orthopaedic osteotome	Uncoated elbow humerus prosthesis Conformity Assessment Certificate Expired	Class IIb
Orthopaedic osteotome	Press-fit hip femur prosthesis modular Conformity Assessment Certificate Expired	Class III
Orthopaedic osteotome	Unicondylar knee insert	Class III
Orthopaedic osteotome	Orthopaedic implant-instrument extension adaptor single-use	Class III
Orthopaedic osteotome	Coated knee femur prosthesis Conformity Assessment Certificate Expired	Class IIb
Orthopaedic osteotome	Orthopaedic osteotome	Class IIb
Orthopaedic osteotome	Orthopaedic osteotome	Class IIb
Orthopaedic osteotome	Orthopaedic osteotome	Class IIb
Orthopaedic osteotome	Orthopaedic osteotome	Class IIa
Orthopaedic osteotome	Orthopaedic osteotome	Class IIb
Orthopaedic osteotome	Orthopaedic osteotome	Class IIa
Orthopaedic osteotome	Orthopaedic osteotome	Class I
Orthopaedic osteotome	Orthopaedic osteotome	Class IIb
Orthopaedic osteotome	Orthopaedic osteotome	Class IIa
Orthopaedic osteotome	Orthopaedic osteotome	Class I
Orthopaedic osteotome	Orthopaedic osteotome	Class IIb
Orthopaedic osteotome	Orthopaedic osteotome	Class I
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class I
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class IIb
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class IIb
Orthopaedic osteotome	Orthopaedic osteotome	Class IIb
Orthopaedic osteotome	Orthopaedic osteotome	Class IIb
Orthopaedic osteotome	Orthopaedic osteotome	Class IIb
Orthopaedic osteotome	Orthopaedic osteotome	Class IIb
Orthopaedic osteotome	Orthopaedic osteotome	Class I
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class IIa
Orthopaedic osteotome	Orthopaedic osteotome	Class IIb
Orthopaedic osteotome	Orthopaedic osteotome	Class I
Orthopaedic osteotome	Orthopaedic osteotome	Class III
Orthopaedic osteotome	Orthopaedic osteotome	Class I
Orthopaedic osteotome	Orthopaedic osteotome	Class I
Orthopaedic osteotome	Orthopaedic osteotome	Class III

Manufacturer's Devices - Zimmer Inc.

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