Identity
- Trade Name
- U2 Hip Stem, Ti Porous Coated, Matrix FDA UDI
- Generic Name
- Coated hip femur prosthesis, modular FDA UDI
- Device Name
- Hip stem, Ti porous coated, matrix, #3, φ12 FDA UDI
- Model / Reference
- 1104-3235 FDA UDI
- Description
- Hip stem, Ti porous coated, matrix, #3, φ12 FDA UDI
Identifiers
- Catalog Number
- 1104-3235 FDA UDI
- Primary DI / UDI-DI
- 04712771495805 FDA UDI
- 510(k) Number
- K151316 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Coated hip femur prosthesis, modular FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 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: Coated hip femur prosthesis, modularRevision coated hip femur prosthesis
U2 Hip Stem, Ti Porous Coated, Matrix by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Revision coated hip femur prosthesis.
- M-Vizion Femoral Revision System — Medacta International · Class II
- M-Vizion Femoral Revision System — Medacta International · Class II
- M-Vizion Femoral Revision System — Medacta International · Class II
- M-Vizion Femoral Revision System — Medacta International · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- UniSyn Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- UniSyn Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- ZMR® — Zimmer, Inc. · Class II
Cleared under the same submission
K151316 also covers:
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
- United Orthopedic Corp.
Sources (1)
- FDA UDI bc38a29f-cb40-4e9e-bdcf-7f0b9734785a 37 fields · synced May 30, 2026