Clearance Summary
P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT received FDA 510(k) clearance under submission number K900638, sponsored by Johnson & Johnson International. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1990-04-30.
- Submission: K900638
- Applicant / Sponsor: Johnson & Johnson International
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3360
- Decision date: 1990-04-30
Classification & Regulation
This clearance is catalogued under FDA product code KWL and 21 CFR 888.3360, within the Orthopedic review panel as a Class II device.