Clearance Summary
P.F.C. BIPOLAR HIP SYSTEM received FDA 510(k) clearance under submission number K931655, 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 1994-06-09.
- Submission: K931655
- Applicant / Sponsor: Johnson & Johnson Orthopaedics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3390
- Decision date: 1994-06-09
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.