Clearance Summary
E1 ANTIOXIDANT INFUSED TECHNOLOGY received FDA 510(k) clearance under submission number K100048, sponsored by Biomet Manufacturing Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2010-03-09.
- Submission: K100048
- Applicant / Sponsor: Biomet Manufacturing Corp
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 2010-03-09
Classification & Regulation
This clearance is catalogued under FDA product code OIY and 21 CFR 888.3560, within the Orthopedic review panel as a Class II device.