K250182
- 510(k) number
- K250182
- Device name
- Innovasis Navigation Instruments
- Applicant
- Innovasis, Inc. UT · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-03-24
- Date received
- 2025-01-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K250182.pdf
Official FDA record: K250182
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.