Oxford® Partial Knee System
Ref 166943
Active
CE MDR
Valid until
6 Nov 2027
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number889024XHL8 00887868354861 | Date3 Sep 2026 | StatusActive |
Certificates
- MDR 754277 Active
Technical documentation EU MDR
- Certifier
- BSI Group The Netherlands B.V. 2797
- Issued
- 11 Aug 2026
- Expires
- 6 Nov 2027
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Oxford High Flex Twin Peg Femoral Components
- Model / Reference
- 166943
- Primary DI / UDI-DI
- 00887868354861
- Basic UDI-DI
- 889024XHL8
- EMDN Code
- P0909040101 Unicompartmental knee prostheses femoral components (unicondylar), cemented
- Device Class
- Class III
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- GB-MF-000001894
- Authorised representative
- Biomet Global Supply Chain Center B.V. NL-AR-000000422
Other devices from Biomet UK Ltd.
Properties
Other properties (11)
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No