510(k) K132704

DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW by Biomet — Product Code LXT

K132704 is an FDA 510(k) premarket notification submitted by Biomet for the device "DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW". The FDA issued a decision of Substantially Equivalent on October 9, 2013. The device falls under product code LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite), a Class II device regulated under 21 CFR 888.3030. Biomet has at least 10 other 510(k) clearances on record.