Clearance Summary
P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR received FDA 510(k) clearance under submission number K945793, sponsored by Johnson & Johnson Professionals, 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 1995-04-10.
- Submission: K945793
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3390
- Decision date: 1995-04-10
Classification & Regulation
This clearance is catalogued under FDA product code KWY and 21 CFR 888.3390, within the Orthopedic review panel as a Class II device.