Identity
- Trade Name
- ENDURANCE FDA UDI
- Generic Name
- Uncoated hip femur prosthesis, modular FDA UDI
- Device Name
- FEMORAL STEM 12/14 TAPER ENDURANCE HIP STEM SIZE 3 200mm CALCAR FDA UDI
- Model / Reference
- 1521-62-000 FDA UDI
- Description
- FEMORAL STEM 12/14 TAPER ENDURANCE HIP STEM SIZE 3 200mm CALCAR FDA UDI
Identifiers
- Catalog Number
- 152162000 FDA UDI
- Primary DI / UDI-DI
- 10603295057338 FDA UDI
- FDA Product Code
- JDI FDA UDI
- GMDN Term
- Uncoated hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Uncoated hip femur prosthesis, modular
Endurance by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II
- SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II
- Omnifit — Howmedica Osteonics Corp. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI 59b68be1-c8af-48ca-96b9-be8e46518bf1 35 fields · synced Jun 8, 2026