510(k) K131974

HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) by Depuy Mitek, A Johnson & Johnson Company — Product Code MAI

K131974 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM)". The FDA issued a decision of Substantially Equivalent on Jul 25, 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.