Clearance Summary
SOUTHERN SPINE ANTERIOR CERVICAL STABILIZATION SYSTEM, KWIK- FIX CERVICAL SYSTEM, AND KWIK-FIX / TS CERVICAL SYSTEM received FDA 510(k) clearance under submission number K063764, sponsored by Southern Spine, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2007-05-16.
- Submission: K063764
- Applicant / Sponsor: Southern Spine, LLC
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2007-05-16
Classification & Regulation
This clearance is catalogued under FDA product code KWQ and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.