K261205
- 510(k) number
- K261205
- Device name
- SPINEART Navigation Instrument System
- Applicant
- Spineart SA CH
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-07-29
- Date received
- 2026-04-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K261205.pdf
Official FDA record: K261205
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.