Identity
- Trade Name
- U2 Total Knee System EUDAMEDTibial insert, PSA type FDA UDI
- Generic Name
- Cruciate-retaining total knee prosthesis FDA UDI
- Device Name
- U2 Total Knee System Tibial Insert, PSA, #3, 11mm Thick EUDAMEDTibial insert, PSA type, #3, 11mm FDA UDI
- Model / Reference
- 2303-5032 EUDAMEDFDA UDI
- Description
- Tibial insert, PSA type, #3, 11mm FDA UDI
Identifiers
- Catalog Number
- 2303-5032 FDA UDI
- Primary DI / UDI-DI
- 04712602348393 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04712602348393 EUDAMED
- 510(k) Number
- K082424 FDA UDI
- FDA Product Code
- JWH FDA UDI
- EMDN Code
- P090905020202 REVISION KNEE PROSTHESES FIXED BEARING TIBIAL INSERTS EUDAMED
- GMDN Term
- Cruciate-retaining 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
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-04712602348393 | 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 637999c4-9c6f-4641-83dd-fe56d2347dfb 61 fields · synced Oct 6, 2026
- FDA UDI dbd04a5b-7f28-42b1-9ed7-92d70583d699 37 fields · synced May 30, 2026