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HSA · registration DE0509174

Zimmer Dual Mobility Vivacit-E Polyethylene Hip Bearings

SingaporeOrthopaedicsClass CZimmer, Inc.
Official record identity
Registration number
DE0509174
Model name
Dual Mobility Vivacit-E Vitamin E Highly Crosslinked Polyethylene Bearing 28 mm I.D. 38 mm O.D. Size C; Dual Mobility Vivacit-E Vitamin E Highly Crosslinked Polyethylene Bearing 28 mm I.D. 40 mm O.D. Size D; Dual Mobility Vivacit-E Vitamin E Highly Crosslinked Polyethylene Bearing 28 mm I.D. 42 mm O.D. Size E; Dual Mobility Vivacit-E Vitamin E Highly Crosslinked Polyethylene Bearing 28 mm I.D. 44 mm O.D. Size F; Dual Mobility Vivacit-E Vitamin E Highly Crosslinked Polyethylene Bearing 28 mm I.D. 46 mm O.D. Size G; Dual Mobility Vivacit-E Vitamin E Highly Crosslinked Polyethylene Bearing 28 mm I.D. 48 mm O.D.; Dual Mobility Vivacit-E Vitamin E Highly Crosslinked Polyethylene Bearing 28 mm I.D. 50 mm O.D. Size H; Dual Mobility Vivacit-E Vitamin E Highly Crosslinked Polyethylene Bearing 28 mm I.D. 52 mm O.D.; Dual Mobility Vivacit-E Vitamin E Highly Crosslinked Polyethylene Bearing 28 mm I.D. 54 mm O.D. Size I; Dual Mobility Vivacit-E Vitamin E Highly Crosslinked Polyethylene Bearing 28 mm I.D. 56 mm O.D.; Dual Mobility Vivacit-E Vitamin E Highly Crosslinked Polyethylene Bearing 28 mm I.D. 58 mm O.D.; Dual Mobility Vivacit-E Vitamin E Highly Crosslinked Polyethylene Bearing 28 mm I.D. 58 mm O.D. Size J; Dual Mobility Vivacit-E Vitamin E Highly Crosslinked Polyethylene Bearing 22.2 mm I.D. 32 mm O.D. Size A; Dual Mobility Vivacit-E Vitamin E Highly Crosslinked Polyethylene Bearing 22.2 mm I.D. 36 mm O.D. Size B
Model identifier
110031009; 110031010; 110031011; 110031012; 110031013; 110031014; 110031015; 110031016; 110031017; 110031018; 110031019; 110031020; 110031313; 110031314
Registration date
April 16, 2024
Classification
Risk class
Class C
Official value: CLASS C
Published category
Orthopaedics
Published parties
Product owner
Zimmer, Inc.
Registrant / registration holder
ZIMMER PTE. LTD.
Official description

• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. • Rheumatoid arthritis. • Correction of functional deformity. • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. • Revision procedures where other treatment or devices have failed. • Dislocation risks. Dual Mobility Hip Bearings are single-use implants, intended for uncemented applications.

Additional source fields
Product owner address
1800 West Center Street, Warsaw, Indiana 46580, United States
Registrant address
401 COMMONWEALTH DRIVE, #06-03, HAW PAR TECHNO CENTRE, Singapore 149598
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.