Clearance Summary
CHARNLEY FEMUR DRILL #1 AND #2 received FDA 510(k) clearance under submission number K760977, sponsored by Codman & Shurtleff, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1976-11-16.
- Submission: K760977
- Applicant / Sponsor: Codman & Shurtleff, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 1976-11-16
Classification & Regulation
This clearance is catalogued under FDA product code HWE and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.