Clearance Summary
Q-FIX ULTRA All-Suture Anchor received FDA 510(k) clearance under submission number K232457, sponsored by Smith & Nephew. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-09-08.
- Submission: K232457
- Applicant / Sponsor: Smith & Nephew
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2023-09-08
Classification & Regulation
This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.