Clearance Summary
APEX HCLA ACETABULAR CUP LINERS received FDA 510(k) clearance under submission number K062489, sponsored by Omnilife Science. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2007-08-15.
- Submission: K062489
- Applicant / Sponsor: Omnilife Science
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 2007-08-15
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.