510(k) K142574

4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, by Depuy Mitek, A Johnson & Johnson Company — Product Code MBI

K142574 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "4.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 5.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture, 6.5mm Healix Ti Anchor, with 2 or 3 strands of #2 Permacord suture,". The FDA issued a decision of Substantially Equivalent on Oct 24, 2014. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Depuy Mitek, A Johnson & Johnson Company has 61 other 510(k) clearances on record.