Identity
- Trade Name
- U2™ Hip FDA UDI
- Generic Name
- Femoral stem prosthesis trial FDA UDI
- Device Name
- Neck trial, #1, #2 FDA UDI
- Model / Reference
- 9104-5002 FDA UDI
- Description
- Neck trial, #1, #2 FDA UDI
Identifiers
- Catalog Number
- 9104-5002 FDA UDI
- Primary DI / UDI-DI
- 04719872170983 FDA UDI
- 510(k) Number
- K112463 FDA UDI
- FDA Product Code
- LPH FDA UDIMEH FDA UDILZO FDA UDI
- GMDN Term
- Femoral stem prosthesis trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Femoral stem prosthesis trial
U2™ Hip by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Femoral stem prosthesis trial.
- S-ROM — DEPUY ORTHOPAEDICS, INC. · Class I
- ARCOS MODULAR REVISION SYSTEM — Biomet Orthopedics, Inc. · Class II
- S-ROM — DEPUY ORTHOPAEDICS, INC. · Class I
- S-ROM — DEPUY ORTHOPAEDICS, INC. · Class I
- MALLORY/HEAD MODULAR — Biomet Orthopedics, Inc. · Class I
- EXACT REVERSE FP FULL TOOTH RASP — Zimmer, Inc. · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- ZMR® — Zimmer, Inc. · Class II
Cleared under the same submission
K112463 also covers:
- Ceramic Femoral Head BIOLOX® Delta 12/14L — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Delta 12/14M — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Delta 12/14S — UNITED ORTHOPEDIC CORP.
- Ceramic Femoral Head BIOLOX® Delta 12/14XL — UNITED ORTHOPEDIC CORP.
- U-Motion II — UNITED ORTHOPEDIC CORP.
- U2™ Hip — UNITED ORTHOPEDIC CORP.
- U2™ Hip — UNITED ORTHOPEDIC CORP.
- U2™ Hip — UNITED ORTHOPEDIC CORP.
- U2™ Hip — UNITED ORTHOPEDIC CORP.
- U2™ Hip — UNITED ORTHOPEDIC CORP.
- U2™ Hip — UNITED ORTHOPEDIC CORP.
- U2™ Hip — UNITED ORTHOPEDIC CORP.
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
- United Orthopedic Corp.
Sources (1)
- FDA UDI fb8b0d35-faa1-4212-a79e-23428b2303a4 37 fields · synced Jun 6, 2026