Identity
- Trade Name
- RECLAIM FDA UDI
- Generic Name
- Press-fit hip femur prosthesis, one-piece FDA UDI
- Device Name
- RECLAIM MONOBLOC REVISION FEMORAL STEM STANDARD STEM STANDARD OFFSET SO 14 CEMENTLESS FDA UDI
- Model / Reference
- 10-185-4014 FDA UDI
- Description
- RECLAIM MONOBLOC REVISION FEMORAL STEM STANDARD STEM STANDARD OFFSET SO 14 CEMENTLESS FDA UDI
Identifiers
- Catalog Number
- 101854014 FDA UDI
- Primary DI / UDI-DI
- 10603295533665 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Press-fit hip femur prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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: Press-fit hip femur prosthesis, one-piece
Reclaim by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Press-fit hip femur prosthesis, one-piece.
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- Amis K Long femoral stems — Medacta International · Class II
- Klassic Blade Femoral Stem, Porous, Size 1 — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- AMIStem-H Proximal Coating — Medacta International · Class II
- Trivicta — ORTHO DEVELOPMENT 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 91773d03-c4ac-4af4-b06c-777a4e551f57 35 fields · synced Jun 8, 2026