Clearance Summary
LATERAL FLARE INTERNAL COLLAR (LFIC) received FDA 510(k) clearance under submission number K971900, sponsored by Pro-Lfic, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1997-12-18.
- Submission: K971900
- Applicant / Sponsor: Pro-Lfic, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3360
- Decision date: 1997-12-18
Classification & Regulation
This clearance is catalogued under FDA product code LWJ and 21 CFR 888.3360, within the Orthopedic review panel as a Class II device.