Pfn
Ref 357.028Model Orthopaedic Spacer and Connector
Withdrawn
CE MDR, withdrawn
Ended
Withdrawn
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00221J2 | Date30 Jul 2025 | StatusWithdrawn |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Withdrawn
Specification
- Device Name
- Orthopaedic Spacer and Connector
- Model / Reference
- Orthopaedic Spacer and Connector, 357.028
- Primary DI / UDI-DI
- 07611819291225
- Basic UDI-DI
- 7611819a00221J2
- EMDN Code
- L0903 Orthopaedic surgery hammers, reusable
- Device Class
- Class I
- Market of Registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CH-MF-000013345
- Authorised representative
- DePuy Ireland UC IE-AR-000009328
Other devices from Synthes GmbH
Properties
Other properties (12)
- Sterile: No
- Implantable: 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