Clearance Summary
CHARNLEY CONGENITAL HIP FEMUR (85-3061) received FDA 510(k) clearance under submission number K761003, sponsored by Codman & Shurtleff, 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 1976-11-23.
- Submission: K761003
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3360
- Decision date: 1976-11-23
Classification & Regulation
This clearance is catalogued under FDA product code JDG and 21 CFR 888.3360, within the Orthopedic review panel as a Class II device.