K251282
- 510(k) number
- K251282
- Device name
- StealthStation S8 Spine Software
- Applicant
- Medtronic Navigation, Inc. CO · US
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2025-10-17
- Date received
- 2025-04-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K251282.pdf
Official FDA record: K251282
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.