Clearance Summary
P.F.C. UNICONDYLAR KNEE SYSTEM received FDA 510(k) clearance under submission number K910968, sponsored by Johnson & Johnson Orthopaedics, 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 1991-08-26.
- Submission: K910968
- Applicant / Sponsor: Johnson & Johnson Orthopaedics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3530
- Decision date: 1991-08-26
Classification & Regulation
This clearance is catalogued under FDA product code HRY and 21 CFR 888.3530, within the Orthopedic review panel as a Class II device.