U2™ Knee 9403-3010-RB
Ref 9403-3010-RB
U2™ Knee 9403-3010-RB is a device classified as Class IIa in the EU and Class I in the US made by United Orthopedic Corp., registered in EUDAMED on 12 Feb 2026 (Basic UDI-DI B-04719872176329) and listed in FDA GUDID since 29 Jun 2017 (UDI-DI 04719872176329), active as of 23 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-04719872176329 04719872176329 | Date12 Feb 2026 | StatusActive |
| United States | GUDID listing GUDID | Number04719872176329 | Date29 Jun 2017 | StatusListed |
Official records
- EUDAMED public site B-04719872176329
- AccessGUDID record 04719872176329
Across registries
- EUDAMED Basic UDI-DI B-04719872176329 registered 12 Feb 2026 Active
- FDA GUDID UDI-DI 04719872176329 listed 29 Jun 2017 Listed
Timeline
- Listed FDA GUDID 04719872176329
- Registered EUDAMED B-04719872176329
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- U2 Total Knee System EUDAMEDU2™ Knee GUDID
- Generic name
- Medullary canal orthopaedic reamer, rigid
- Model / Ref / Catalog
- 9403-3010-RB
- Primary DI / UDI-DI
- 04719872176329
- Basic UDI-DI
- B-04719872176329
- FDA product code
- HTO
- EMDN code
- L091102 Orthopaedic prostheses reamers and burs, reusable
- GMDN term
- Medullary canal orthopaedic reamer, rigid
- Device class
- Class IIa EUDAMEDClass I GUDID
- Regulation number
- 888.4540
- EU registration type
- Legacy device (under a directive)
- EU market of registration
- France
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class IIa | Class I |
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