K240647
- 510(k) number
- K240647
- Device name
- Virage® Navigation System
- Applicant
- Zimvie Spine (Zimmer Biomet Spine, Inc.) CO · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-04-05
- Date received
- 2024-03-07
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K240647.pdf
Official FDA record: K240647
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.