Clearance Summary
44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM received FDA 510(k) clearance under submission number K093549, sponsored by Biomet Manufacturing Corp. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2009-12-16.
- Submission: K093549
- Applicant / Sponsor: Biomet Manufacturing Corp
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 2009-12-16
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.