Clearance Summary
OSTEONICS SERIES 7000 AD TIBIAL TRAY received FDA 510(k) clearance under submission number K983657, sponsored by Osteonics 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 2000-04-06.
- Submission: K983657
- Applicant / Sponsor: Osteonics Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3530
- Decision date: 2000-04-06
Classification & Regulation
This clearance is catalogued under FDA product code HRY and 21 CFR 888.3530, within the Orthopedic review panel as a Class II device.