Clearance Summary
Mazor X System (Mazor X Stealth Edition) received FDA 510(k) clearance under submission number K230064, 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 2023-04-07.
- Submission: K230064
- Applicant / Sponsor: Mazor Robotics , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2023-04-07
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.