Identity
- Trade Name
- U2 Femoral Head EUDAMEDFDA UDI
- Generic Name
- Femoral head prosthesis trial FDA UDI
- Device Name
- U2 Femoral head trial, Ø28mm, -3mm EUDAMEDFDA UDI
- Model / Reference
- 1206-2028-RC EUDAMEDFDA UDI
- Description
- U2 Femoral head trial, Ø28mm, -3mm FDA UDI
Identifiers
- Catalog Number
- 1206-2028-RC FDA UDI
- Primary DI / UDI-DI
- 04711605586818 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04711605586818 EUDAMED
- 510(k) Number
- K162957 FDA UDI
- FDA Product Code
- LPH FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Femoral head prosthesis trial FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3358 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
U2 Femoral Head by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K162957 also covers:
- U2 Femoral Head — UNITED ORTHOPEDIC CORP.
- U2 Femoral Head — UNITED ORTHOPEDIC CORP.
- U2 Femoral Head — UNITED ORTHOPEDIC CORP.
- U2 Femoral Head — UNITED ORTHOPEDIC CORP.
- U2 Femoral head, 3/4 polished, Ø22mm, +0mm — UNITED ORTHOPEDIC CORP.
- U2 Femoral head, 3/4 polished, Ø22mm, +6mm — UNITED ORTHOPEDIC CORP.
- U2 Femoral head, 3/4 polished, Ø26mm, +6mm — UNITED ORTHOPEDIC CORP.
- U2 Femoral head, 3/4 polished, Ø28mm, +7.5mm — UNITED ORTHOPEDIC CORP.
- U2 Femoral head, 3/4 polished, Ø28mm, -3mm — UNITED ORTHOPEDIC CORP.
- U2 Femoral head, 3/4 polished, Ø32mm, +10mm — UNITED ORTHOPEDIC CORP.
- U2 Femoral head, 3/4 polished, Ø32mm, +2.5mm — UNITED ORTHOPEDIC CORP.
- U2 Femoral head, 3/4 polished, Ø32mm, +5mm — 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 |
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Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (2)
- FDA UDI 0a3e6570-e8f8-4062-a1e6-b373cbeced8d 36 fields · synced Oct 7, 2026
- EUDAMED 3e3819f3-415f-4a04-88e6-42e48cd59827 61 fields · synced Aug 4, 2026