Identity
- Trade Name
- S-ROM FDA UDI
- Generic Name
- Uncoated hip femur prosthesis, modular FDA UDI
- Device Name
- S-ROM Total Hip System FEMORAL STEM STANDARD 36 STD NECK 16 x 10 x 150 11/13 TAPER FDA UDI
- Model / Reference
- 87-5971 FDA UDI
- Description
- S-ROM Total Hip System FEMORAL STEM STANDARD 36 STD NECK 16 x 10 x 150 11/13 TAPER FDA UDI
Identifiers
- Catalog Number
- 875971 FDA UDI
- Primary DI / UDI-DI
- 10603295218913 FDA UDI
- 510(k) Number
- K851422 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
Category: Uncoated hip femur prosthesis, modular
S-Rom by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Uncoated hip femur prosthesis, modular.
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- SPII Model Lubinus — WALDEMAR LINK GmbH & Co. KG · Class II
- 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
Cleared under the same submission
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 1df3f5aa-6136-4a50-a7b1-2f113df25038 36 fields · synced Jun 8, 2026