Clearance Summary
SECULOK Suture Anchor received FDA 510(k) clearance under submission number K180759, sponsored by U&I Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-08-09.
- Submission: K180759
- Applicant / Sponsor: U&I Corporation
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2018-08-09
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.