Clearance Summary
HUMERUS WIRES received FDA 510(k) clearance under submission number K964243, sponsored by Compagnie Financiere & Medicale (Cf&M). The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1996-12-05.
- Submission: K964243
- Applicant / Sponsor: Compagnie Financiere & Medicale (Cf&M)
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3020
- Decision date: 1996-12-05
Classification & Regulation
This clearance is catalogued under FDA product code HSB and 21 CFR 888.3020, within the Orthopedic review panel as a Class II device.