K254158
- 510(k) number
- K254158
- Device name
- SPINEART Navigation Instrument System
- Applicant
- Spineart SA CH
- Product code
- OLO — Orthopedic Stereotaxic Instrument
- Decision date
- 2026-04-09
- Date received
- 2025-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K254158.pdf
Official FDA record: K254158
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.