Clearance Summary
EMERALD SPINAL SYSTEM received FDA 510(k) clearance under submission number K101446, sponsored by Mazor Surgical Technologies , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-01-20.
- Submission: K101446
- Applicant / Sponsor: Mazor Surgical Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2011-01-20
Classification & Regulation
This clearance is catalogued under FDA product code MNH and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.