Clearance Summary
P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL received FDA 510(k) clearance under submission number K914439, 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 1991-10-23.
- Submission: K914439
- Applicant / Sponsor: Johnson & Johnson Orthopaedics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3520
- Decision date: 1991-10-23
Classification & Regulation
This clearance is catalogued under FDA product code HSX and 21 CFR 888.3520, within the Orthopedic review panel as a Class II device.