Clearance Summary
BACFIX SPINAL FIXATION SYSTEM received FDA 510(k) clearance under submission number K964404, sponsored by Spinal Concepts, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1997-03-26.
- Submission: K964404
- Applicant / Sponsor: Spinal Concepts, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3050
- Decision date: 1997-03-26
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.