Locking Screw TAN
Ref 413.085SModel Locking Screw TAN
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Overview
Unlocking the full potential of your patients with our innovative Locking Screw TAN device, which offers unparalleled precision and reliability in orthopedic surgery. Designed to meet the highest standards of FDA compliance, this device is engineered for efficiency and durability, ensuring optimal outcomes for surgeons and clinicians alike.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00429JU 07611819898028 | Date8 Aug 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- Withdrawn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
- Locking Screw TAN, 413.085S
- Primary DI / UDI-DI
- 07611819898028
- Basic UDI-DI
- 7611819a00429JU
- 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 (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