510(k) K120449

HEALIX ADVANCE PEEK ANCHOR by Depuy Mitek — Product Code HWC

K120449 is an FDA 510(k) premarket notification submitted by Depuy Mitek for the device "HEALIX ADVANCE PEEK ANCHOR". The FDA issued a decision of Substantially Equivalent on May 11, 2012. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Depuy Mitek has at least 10 other 510(k) clearances on record.