Synapse
Ref 04.614.512SModel Connecting Rods for Spine Connecting Rod
Withdrawn
CE MDR, withdrawn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Withdrawn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 | Number7611819a00441JJ 07611819328785 | Date8 Aug 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- Withdrawn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European Union — CE/MDR Withdrawn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
- Connecting Rod
- Model / Reference
- Connecting Rods for Spine Connecting Rod, 04.614.512S
- Primary DI / UDI-DI
- 07611819328785
- Basic UDI-DI
- 7611819a00441JJ
- EMDN Code
- P09070304 Spine fixation system connectors
- Device Class
- Class IIb
- EU 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 (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