Clearance Summary
TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY received FDA 510(k) clearance under submission number K911198, sponsored by Orthomet, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1991-05-23.
- Submission: K911198
- Applicant / Sponsor: Orthomet, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 1991-05-23
Classification & Regulation
This clearance is catalogued under FDA product code JWH and 21 CFR 888.3560, within the Orthopedic review panel as a Class II device.