510(k) K111779

Y-KNOT ALL-SUTURE ANCHOR MODEL HF13 by Conmed Linvatec — Product Code MBI

K111779 is an FDA 510(k) premarket notification submitted by Conmed Linvatec for the device "Y-KNOT ALL-SUTURE ANCHOR MODEL HF13". The FDA issued a decision of Substantially Equivalent on August 8, 2011. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Conmed Linvatec has at least 10 other 510(k) clearances on record.