510(k) K934366

MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER by Mitek Surgical Products, Inc. — Product Code HWC

K934366 is an FDA 510(k) premarket notification submitted by Mitek Surgical Products, Inc. for the device "MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER". The FDA issued a decision of SN on October 7, 1994. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Mitek Surgical Products, Inc. has at least 10 other 510(k) clearances on record.