510(k) K131035

Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM by Linvatec Corporation D/B/A Conmed Linvatec — Product Code MBI

K131035 is an FDA 510(k) premarket notification submitted by Linvatec Corporation D/B/A Conmed Linvatec for the device "Y-KNOT FLEX ALL-SUTURE ANCHOR, W/ TWO #2 (5 METRIC) HI-FI SUTURES, 1.8MM". The FDA issued a decision of Substantially Equivalent on July 2, 2013. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Linvatec Corporation D/B/A Conmed Linvatec has at least 3 other 510(k) clearances on record.