Identity
- Trade Name
- U2 Total Knee System EUDAMEDStraight stem, PSA type FDA UDI
- Generic Name
- Posterior-stabilized total knee prosthesis FDA UDI
- Device Name
- U2 Total Knee System Straight Stem, PSA, 24mm Dia., 100mm Stem Length EUDAMEDStraight stem, PSA type, Ø24x100mm FDA UDI
- Model / Reference
- 2703-5028 EUDAMEDFDA UDI
- Description
- Straight stem, PSA type, Ø24x100mm FDA UDI
Identifiers
- Catalog Number
- 2703-5028 FDA UDI
- Primary DI / UDI-DI
- 04712771480696 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04712771480696 EUDAMED
- 510(k) Number
- K082424 FDA UDI
- FDA Product Code
- JWH FDA UDI
- EMDN Code
- P0909800601,P0909800602 EUDAMED
- GMDN Term
- Posterior-stabilized total knee prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 100 Millimeter FDA UDI
U2 Total Knee System by United Orthopedic Corporation — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04712771480696 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- United Orthopedic Corporation
- EUDAMED SRN
- TW-MF-000009523
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 3fb2748d-ddff-4806-a397-cf213a412167 61 fields · synced Jun 9, 2026
- FDA UDI c307ba41-dc5a-42fe-969e-d7bf315a76b1 37 fields · synced May 30, 2026