Ceramic Femoral Head
by United Orthopedic Corporation EUDAMED
Active
Ref 1203-7040, 1203-7236, 1203-7432, 1203-7440
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-04712771506549 | Date27 Dec 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDD Expiring
Specification
- Device Name
- Ceramic Femoral Head BIOLOX® OPTION, 40mm Dia., 12/14 Taper, Small, -2Ceramic Femoral Head BIOLOX® OPTION, 36mm Dia., 12/14 Taper, Medium, +1Ceramic Femoral Head BIOLOX® OPTION, 32mm Dia., 12/14 Taper, Large, +5Ceramic Femoral Head BIOLOX® OPTION, 40mm Dia., 12/14 Taper, Large, +5
- Model / Reference
- 1203-7040, 1203-7236, 1203-7432, 1203-7440
- Primary DI / UDI-DI
- 04712771506549, 04712771506518, 04712771506488, 04712771506563
- Basic UDI-DI
- B-04712771506549, B-04712771506518, B-04712771506488, B-04712771506563
- EMDN Code
- P0908040504 Revision femoral heads
- Device Class
- Class III
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- TW-MF-000009523
- Authorised representative
- mdi Europa GmbH DE-AR-000006218
Other devices from United Orthopedic Corp.
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