510(k) K131683

HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) by Depuy Mitek, Inc., A Johnson and Johnson Company — Product Code MBI

K131683 is an FDA 510(k) premarket notification submitted by Depuy Mitek, Inc., A Johnson and Johnson Company for the device "HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM)". The FDA issued a decision of Substantially Equivalent on June 27, 2013. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Depuy Mitek, Inc., A Johnson and Johnson Company has at least 2 other 510(k) clearances on record.