Clearance Summary
OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION) received FDA 510(k) clearance under submission number K964924, sponsored by Osteoimplant Technology, 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 1997-03-07.
- Submission: K964924
- Applicant / Sponsor: Osteoimplant Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 1997-03-07
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.