Identity
- Trade Name
- RECLAIM FDA UDI
- Generic Name
- Press-fit hip femur prosthesis, one-piece FDA UDI
- Device Name
- RECLAIM MONOBLOC REVISION FEMORAL STEM LONG STEM STANDARD OFFSET SO 15 CEMENTLESS FDA UDI
- Model / Reference
- 10-235-4015 FDA UDI
- Description
- RECLAIM MONOBLOC REVISION FEMORAL STEM LONG STEM STANDARD OFFSET SO 15 CEMENTLESS FDA UDI
Identifiers
- Catalog Number
- 102354015 FDA UDI
- Primary DI / UDI-DI
- 10603295533870 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 (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Press-fit hip femur prosthesis, one-piece.
- Masterloc Femoral Stems — Medacta International · Class II
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED · Class II
- AMIStem H Femoral Stems — Medacta International · Class II
- Quadra H femoral stems — Medacta International · Class II
- 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 (ireland)
Sources (1)
- FDA UDI 030ee4bf-1abe-4cd5-89fe-aa9eec3ae333 35 fields · synced Jun 8, 2026