Identity
- Trade Name
- U2™ Knee FDA UDI
- Generic Name
- Femoral stem prosthesis trial FDA UDI
- Device Name
- Curved stem trial , PSA , φ19 × 150mm FDA UDI
- Model / Reference
- 2703-6136 FDA UDI
- Description
- Curved stem trial , PSA , φ19 × 150mm FDA UDI
Identifiers
- Catalog Number
- 2703-6136 FDA UDI
- Primary DI / UDI-DI
- 04719872170518 FDA UDI
- FDA Product Code
- JWH FDA UDIMBH FDA UDIOIY FDA UDI
- GMDN Term
- Femoral stem prosthesis trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3565 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™ Knee 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
K122183 also covers:
- Femoral augment, distal only — UNITED ORTHOPEDIC CORP.
- Femoral augment, distal only — UNITED ORTHOPEDIC CORP.
- Tibial augment, screw locking — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
K161360 also covers:
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2 Total Knee System — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
K161705 also covers:
- E-XPE Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PS — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PSA — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PSA — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PSA — UNITED ORTHOPEDIC CORP.
- E-XPE Tibial insert, PSA — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — UNITED ORTHOPEDIC CORP.
- U2™ Knee — 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 d9c61997-8c60-4d30-a7ac-6275f4994426 37 fields · synced May 30, 2026