K251073
- 510(k) number
- K251073
- Device name
- Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
- Applicant
- Innovasis, Inc. UT · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-07-23
- Date received
- 2025-04-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K251073.pdf
Official FDA record: K251073
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.