Clearance Summary
UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM received FDA 510(k) clearance under submission number K974331, 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 1998-02-06.
- Submission: K974331
- Applicant / Sponsor: Johnson & Johnson Professionals, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 1998-02-06
Classification & Regulation
This clearance is catalogued under FDA product code LPH and 21 CFR 888.3358, within the Orthopedic review panel as a Class II device.