Clearance Summary
PLC SUTURE ANCHOR received FDA 510(k) clearance under submission number K063726, sponsored by Smith & Nephew Inc., Endoscopy Div.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2007-03-06.
- Submission: K063726
- Applicant / Sponsor: Smith & Nephew Inc., Endoscopy Div.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2007-03-06
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.