Clearance Summary
FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING received FDA 510(k) clearance under submission number K122239, sponsored by Encore Medical L.P.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-04-11.
- Submission: K122239
- Applicant / Sponsor: Encore Medical L.P.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 2013-04-11
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.