Clearance Summary
SPINEASSIST DEVICE received FDA 510(k) clearance under submission number K033413, sponsored by Mazor Surgical Technologies , 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 2004-01-07.
- Submission: K033413
- Applicant / Sponsor: Mazor Surgical Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2004-01-07
Classification & Regulation
This clearance is catalogued under FDA product code HAW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.