510(k) K100618

MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY by Orthohelix Surgical Designs, Inc. — Product Code HRS

K100618 is an FDA 510(k) premarket notification submitted by Orthohelix Surgical Designs, Inc. for the device "MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY". The FDA issued a decision of Substantially Equivalent on April 20, 2010. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Orthohelix Surgical Designs, Inc. has at least 10 other 510(k) clearances on record.