510(k) K073412

GRYPHON BR AND HEALIX BR ANCHORS by Depuy Mitek, A Johnson & Johnson Company — Product Code MAI

K073412 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "GRYPHON BR AND HEALIX BR ANCHORS". The FDA issued a decision of Substantially Equivalent on Jan 17, 2008. 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.