Clearance Summary
INVISIKNOT Ankle Syndesmosis Repair Kit received FDA 510(k) clearance under submission number K162996, sponsored by Smith & Nephew, 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 2017-06-08.
- Submission: K162996
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2017-06-08
Classification & Regulation
This clearance is catalogued under FDA product code HTN and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.