Identity
- Trade Name
- U2 Femoral Head FDA UDI
- Generic Name
- Femoral head prosthesis trial FDA UDI
- Device Name
- U2 Femoral head trial, Ø36mm, +2.5mm FDA UDI
- Model / Reference
- 1206-2236-RC FDA UDI
- Description
- U2 Femoral head trial, Ø36mm, +2.5mm FDA UDI
Identifiers
- Catalog Number
- 1206-2236-RC FDA UDI
- Primary DI / UDI-DI
- 04711605586917 FDA UDI
- 510(k) Number
- K162957 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Femoral head prosthesis trial 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
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 head prosthesis trial
U2 Femoral Head by United Orthopedic Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162957 also covers:
- 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.
- U2 Femoral head, 3/4 polished, Ø32mm, +7.5mm — UNITED ORTHOPEDIC CORP.
- U2 Femoral head, 3/4 polished, Ø36mm, +10mm — 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 (1)
- FDA UDI 5fec03f3-cff9-429d-8047-80cf347ef0e7 36 fields · synced May 29, 2026