Clearance Summary
KESTREL POSTERIOR CERVICAL SPINE SYSTEM received FDA 510(k) clearance under submission number K132122, sponsored by Omni Surgical, LLC Dba Spine360. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2014-01-22.
- Submission: K132122
- Applicant / Sponsor: Omni Surgical, LLC Dba Spine360
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3050
- Decision date: 2014-01-22
Classification & Regulation
This clearance is catalogued under FDA product code KWP and 21 CFR 888.3050, within the Orthopedic review panel as a Class II device.