Identity
- Trade Name
- U2 Total Knee System EUDAMEDFDA UDI
- Generic Name
- Knee femur prosthesis trial, reusable FDA UDI
- Device Name
- CR Notch trial, #1.5 EUDAMEDFDA UDI
- Model / Reference
- 9304-5215 EUDAMEDFDA UDI
- Description
- CR Notch trial, #1.5 FDA UDI
Identifiers
- Catalog Number
- 9304-5215 FDA UDI
- Primary DI / UDI-DI
- 04719886890532 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04719886890532 EUDAMED
- 510(k) Number
- K221705 FDA UDI
- FDA Product Code
- MBH FDA UDIJWH FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Knee femur prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3565 FDA UDI888.3560 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 Total Knee System by United Orthopedic Corporation — Class IIa — 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-04719886890532 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 b386f5db-c08c-4529-a58d-06f1ac08f302 61 fields · synced Jun 9, 2026
- FDA UDI 56c8b09e-4d73-41b7-a283-90f38158c443 36 fields · synced May 30, 2026