Clearance Summary
GENESIS II TOTAL KNEE SYSTEM received FDA 510(k) clearance under submission number K030612, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2003-05-27.
- Submission: K030612
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3565
- Decision date: 2003-05-27
Classification & Regulation
This clearance is catalogued under FDA product code MBH and 21 CFR 888.3565, within the Orthopedic review panel as a Class II device.