Clearance Summary
SPINEART Navigation Instrument System received FDA 510(k) clearance under submission number K254158, sponsored by Spineart SA. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-04-09.
- Submission: K254158
- Applicant / Sponsor: Spineart SA
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2026-04-09
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.