510(k) K102156

MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS by Orthohelix Surgical Designs, Inc. — Product Code HRS

K102156 is an FDA 510(k) premarket notification submitted by Orthohelix Surgical Designs, Inc. for the device "MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS". The FDA issued a decision of Substantially Equivalent on September 30, 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.