Clearance Summary
Mazor X System / Mazor X Stealth Edition received FDA 510(k) clearance under submission number K251316, sponsored by Mazor Robotics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2025-09-11.
- Submission: K251316
- Applicant / Sponsor: Mazor Robotics , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2025-09-11
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.