Identity
- Trade Name
- RECLAIM FDA UDI
- Generic Name
- Uncoated hip femur prosthesis, modular FDA UDI
- Device Name
- RECLAIM REVISION HIP SYSTEM CONICAL PROXIMAL BODY CEMENTLESS TENSILE BAR 28mm x 85mm 85mm LOCKING BOLT FDA UDI
- Model / Reference
- 1975-28-085 FDA UDI
- Description
- RECLAIM REVISION HIP SYSTEM CONICAL PROXIMAL BODY CEMENTLESS TENSILE BAR 28mm x 85mm 85mm LOCKING BOLT FDA UDI
Identifiers
- Catalog Number
- 197528085 FDA UDI
- Primary DI / UDI-DI
- 10603295076964 FDA UDI
- 510(k) Number
- K102080 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Uncoated hip femur prosthesis, modular 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
Category: Uncoated hip femur prosthesis, modular
Reclaim by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated hip femur prosthesis, modular.
- Accolade — Howmedica Osteonics Corp. · Class II
- SUMMIT — DEPUY ORTHOPAEDICS, INC. · Class II
- S-ROM — DEPUY ORTHOPAEDICS, INC. · Class III
- Corin Taper-Fit Total Hip System — CORIN LTD · Class II
- TaperFit Cemented Hip System — CORIN LTD · Class II
- Omnifit — Howmedica Osteonics Corp. · Class II
- SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II
- SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II
Cleared under the same submission
K102080 also covers:
- RECLAIM — DEPUY (IRELAND)
- RECLAIM — DEPUY (IRELAND)
- RECLAIM — DEPUY (IRELAND)
- RECLAIM — DEPUY (IRELAND)
- RECLAIM — DEPUY (IRELAND)
- RECLAIM — DEPUY (IRELAND)
- RECLAIM — DEPUY (IRELAND)
- RECLAIM — DEPUY (IRELAND)
- RECLAIM — DEPUY (IRELAND)
- RECLAIM — DEPUY (IRELAND)
- RECLAIM — DEPUY (IRELAND)
- RECLAIM — DEPUY (IRELAND)
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Depuy (ireland)
Sources (1)
- FDA UDI f00a0de9-05b3-4cdc-9c24-7c4125a998d2 36 fields · synced May 30, 2026