510(k) K013572

MITEK BIOCRYL INTERFERENCE SCREWS by Mitek Products — Product Code HWC

K013572 is an FDA 510(k) premarket notification submitted by Mitek Products for the device "MITEK BIOCRYL INTERFERENCE SCREWS". The FDA issued a decision of Substantially Equivalent on March 14, 2002. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Mitek Products has at least 10 other 510(k) clearances on record.