Clearance Summary
FAST-FIX FLEX received FDA 510(k) clearance under submission number K203393, sponsored by Smith & Nephew, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2021-02-01.
- Submission: K203393
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.5000
- Decision date: 2021-02-01
Classification & Regulation
This clearance is catalogued under FDA product code GAT and 21 CFR 878.5000, within the General, Plastic Surgery review panel as a Class II device.