Knee Instruments 02.12.10.0625
Ref 02.12.10.0625
Knee Instruments 02.12.10.0625 is a Class I device made by Medacta International SA, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 764014274KSR0331N00B9) and listed in FDA GUDID since 13 Apr 2021 (UDI-DI 07630040793858), active as of 12 Nov 2026.
Active
CE MDR
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/MDR EUDAMED | Number764014274KSR0331N00B9 07630040793858 | Date1 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07630040793858 | Date13 Apr 2021 | StatusListed |
Official records
- EUDAMED public site 764014274KSR0331N00B9
- AccessGUDID record 07630040793858
Across registries
- EUDAMED Basic UDI-DI 764014274KSR0331N00B9 registered 1 Oct 2026 Active
- FDA GUDID UDI-DI 07630040793858 listed 13 Apr 2021 Listed
Timeline
- Listed FDA GUDID 07630040793858
- Registered EUDAMED 764014274KSR0331N00B9
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Offset adapter - Left EUDAMEDKnee Instruments GUDID
- Generic name
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device name
- Knee Sensor holder / Rigid body
- Model / reference
- 02.12.10.0625
- Primary DI / UDI-DI
- 07630040793858
- Basic UDI-DI
- 764014274KSR0331N00B9
- Direct marketing DI
- 07630040793858
- FDA product code
- LXH
- EMDN code
- Z12011480 Surgical navigation instruments - hardware accessories
- GMDN term
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device class
- Class I
- Regulation number
- 888.4540
- EU registration type
- Standard device
- EU market of registration
- Italy
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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