Clearance Summary
PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT received FDA 510(k) clearance under submission number K063211, sponsored by Stelkast Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2007-01-18.
- Submission: K063211
- Applicant / Sponsor: Stelkast Company
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 2007-01-18
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.