510(k) K162124

Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins by DePuy Synthes — Product Code JDP

K162124 is an FDA 510(k) premarket notification submitted by DePuy Synthes for the device "Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins". The FDA issued a decision of Substantially Equivalent on March 29, 2017. The device falls under product code JDP (Condylar Plate Fixation Implant), a Class II device regulated under 21 CFR 888.3030. DePuy Synthes has at least 10 other 510(k) clearances on record.