Clearance Summary
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD received FDA 510(k) clearance under submission number K101451, sponsored by Omni Life Science, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2010-06-22.
- Submission: K101451
- Applicant / Sponsor: Omni Life Science, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 2010-06-22
Classification & Regulation
This clearance is catalogued under FDA product code LZO and 21 CFR 888.3353, within the Orthopedic review panel as a Class II device.