VADER Pedicle System, Navigated Cannulated Polyaxial Screwdriver, T20 42-690N
by Icotec EUDAMEDGUDID
Active
Ref 42-690NModel Bone Screw Final Driver Nav.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number764017255iNPSI0005Y9 | Date5 Aug 2026 | StatusActive |
| United States | GUDID listing GUDID | Number07640172552315 | Date8 Aug 2023 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 23 Oct 2026.
Specification
- Trade Name
- VADER® Pedicle System, Navigated Cannulated Polyaxial Screwdriver T20 EUDAMEDVADER Pedicle System, Navigated Cannulated Polyaxial Screwdriver, T20 GUDID
- Generic Name
- Surgical screwdriver, reusable
- Model / Ref / Catalog
- 42-690N, Bone Screw Final Driver Nav.
- Primary DI / UDI-DI
- 07640172552315
- Basic UDI-DI
- 764017255iNPSI0005Y9
- Direct Marketing DI
- 07640172552315
- FDA Product Code
- OLO
- EMDN Code
- L1109 Neurosurgery and spinal surgery instrument kits, reusable
- GMDN Term
- Surgical screwdriver, reusable
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 882.4560
- Market of Registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Other devices from Icotec
Properties
Other properties (21)
- Sterile: No
- Single Use: No
- Implantable: 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No