510(k) K130917

HEALIX ADVANCE KNOTLESS BR ANCHOR by Depuy Mitek, A Johnson & Johnson Company — Product Code MAI

K130917 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "HEALIX ADVANCE KNOTLESS BR ANCHOR". The FDA issued a decision of Substantially Equivalent on May 24, 2013. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Depuy Mitek, A Johnson & Johnson Company has 61 other 510(k) clearances on record.