Stardrive
by Synthes GmbH 1,000+ variants
Ref 02.210.956SModel Cortex Screw Stainless Steel
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Overview
The STARDRIVE medical device is a premium-grade surgical instrument designed for complex orthopedic procedures. Made from high-quality stainless steel, this versatile tool features advanced micro-mechanical technology, providing precise control and enhanced maneuverability. Its durable design ensures reliability and long-term performance, making it an ideal choice for surgeons and orthopedic professionals.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number7611819a00416JK 07611819444447 | 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- Withdrawn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
- Device Name
- Cortex Screw Stainless Steel
- Model / Reference
- Cortex Screw Stainless Steel, 02.210.956S
- Primary DI / UDI-DI
- 07611819444447
- Basic UDI-DI
- 7611819a00416JK
- 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