K233725
- 510(k) number
- K233725
- Device name
- Spine Navigation System
- Applicant
- Medivis, Inc. NY · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2024-07-26
- Date received
- 2023-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K233725.pdf
Official FDA record: K233725
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.