K250332
- 510(k) number
- K250332
- Device name
- Virage® OCT Spinal Fixation System
- Applicant
- Highridge Medical, LLC CO · US
- Product code
- NKG — Posterior Cervical Screw System
- Decision date
- 2025-04-04
- Date received
- 2025-02-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K250332.pdf
Official FDA record: K250332
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.