Clearance Summary
Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM received FDA 510(k) clearance under submission number K131035, sponsored by Linvatec Corporation D/B/A Conmed Linvatec. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2013-07-02.
- Submission: K131035
- Applicant / Sponsor: Linvatec Corporation D/B/A Conmed Linvatec
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2013-07-02
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.