Clearance Summary
APEX MODULAR ALUMINA FEMORAL HEAD received FDA 510(k) clearance under submission number K012918, sponsored by Apex Surgical, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2001-11-27.
- Submission: K012918
- Applicant / Sponsor: Apex Surgical, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 2001-11-27
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.