Clearance Summary
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) received FDA 510(k) clearance under submission number K082468, sponsored by Omni Life Science, 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 2009-02-18.
- Submission: K082468
- Applicant / Sponsor: Omni Life Science, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3390
- Decision date: 2009-02-18
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.