Zero-P
Ref 03.617.781Model Spine Trial Implants for Zero-P
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00528JX 07611819933002 | Date11 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Zero-P Trial Spacer Parallel Lordotic Convex Large
- Model / Reference
- Spine Trial Implants for Zero-P, 03.617.781
- Primary DI / UDI-DI
- 07611819933002
- Basic UDI-DI
- 7611819a00528JX
- Direct Marketing DI
- 07611819933002
- EMDN Code
- Z12139099 Various orthopaedic and traumatology instruments - other
- Device Class
- Class IIa
- 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 (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No