K232628
- 510(k) number
- K232628
- Device name
- VADER® Pedicle System
- Applicant
- Icotec AG CH
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2024-02-26
- Date received
- 2023-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K232628.pdf
Official FDA record: K232628
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.