Clearance Summary
HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT received FDA 510(k) clearance under submission number K913916, sponsored by Smith & Nephew Richards, 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 1991-12-09.
- Submission: K913916
- Applicant / Sponsor: Smith & Nephew Richards, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 1991-12-09
Classification & Regulation
This clearance is catalogued under FDA product code MEH and 21 CFR 888.3353, within the Orthopedic review panel as a Class II device.