K242900
- 510(k) number
- K242900
- Device name
- VADER® Pedicle System and VADER®one Pedicle System
- Applicant
- Icotec AG CH
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2025-02-27
- Date received
- 2024-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K242900.pdf
Official FDA record: K242900
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.