Cortex Screw TiCP
Ref 402.806Model Cortex Screw TiCP
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Overview
The Cortex Screw TiCP is a Class IIb medical device designed for orthopedic procedures, providing precise screw placement and biocompatibility. Developed by Synthes GmbH, this device is suitable for implanting screws into bone tissue, ideal for spinal fusion surgeries or orthopedic implants.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00418JP 07611819093515 | Date10 Nov 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- Withdrawn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
- Model / Reference
- Cortex Screw TiCP, 402.806
- Primary DI / UDI-DI
- 07611819093515
- Basic UDI-DI
- 7611819a00418JP
- EMDN Code
- P09120601 Cortical screws
- 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 (12)
- Sterile: No
- 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