Clearance Summary
TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER received FDA 510(k) clearance under submission number K946313, sponsored by Smith and Nephew Donjoy, 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 1995-03-17.
- Submission: K946313
- Applicant / Sponsor: Smith and Nephew Donjoy, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1995-03-17
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.