510(k) K100532

VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 by Depuy Mitek, A Johnson & Johnson Company — Product Code HWC

K100532 is an FDA 510(k) premarket notification submitted by Depuy Mitek, A Johnson & Johnson Company for the device "VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819". The FDA issued a decision of Substantially Equivalent on Mar 17, 2010. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Depuy Mitek, A Johnson & Johnson Company has 61 other 510(k) clearances on record.