Virage® OCT Spinal Fixation System— 510(k) K250332
Substantially EquivalentHighridge Medical, LLC
FDA 510(k) clearance K250332 for Virage® OCT Spinal Fixation System, Substantially Equivalent on 2025-04-04. Applicant: Highridge Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Highridge Medical, LLC
- Product code
- Code NKG
- Device class
- Class 2
- Regulation
- 21 CFR 888.3075
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westminister, CO, US
Recent devices under product code NKG
view allMore clearances from Highridge Medical, LLC
view allAdverse events under product code NKG
product code NKG- Death
- 15
- Injury
- 1,090
- Malfunction
- 529
- Total
- 1,634
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.