Clearance Summary
SMITH & NEPHEW PATELLO-FEMORAL IMPLANT received FDA 510(k) clearance under submission number K051086, 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 2005-05-31.
- Submission: K051086
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3540
- Decision date: 2005-05-31
Classification & Regulation
This clearance is catalogued under FDA product code KRR and 21 CFR 888.3540, within the Orthopedic review panel as a Class II device.