510(k) K163046

DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long by DePuy Synthes — Product Code HRS

K163046 is an FDA 510(k) premarket notification submitted by DePuy Synthes for the device "DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long". The FDA issued a decision of Substantially Equivalent on February 9, 2017. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. DePuy Synthes has at least 10 other 510(k) clearances on record.