Clearance Summary
ARAI Surgical Navigation System received FDA 510(k) clearance under submission number K211254, sponsored by Surgalign Spine Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2022-01-14.
- Submission: K211254
- Applicant / Sponsor: Surgalign Spine Technologies
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2022-01-14
Classification & Regulation
This clearance is catalogued under FDA product code SBF and 21 CFR 882.4560, within the Neurology review panel as a Class II device.