Clearance Summary
KNEE PROSTHESIS DRIVER received FDA 510(k) clearance under submission number K915776, sponsored by Kim-Med, 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 1992-06-11.
- Submission: K915776
- Applicant / Sponsor: Kim-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 1992-06-11
Classification & Regulation
This clearance is catalogued under FDA product code HWR and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.