510(k) K201578

DePuy Synthes Variable Angle Locking Patella Plating System by Synthes (USA) Products, LLC — Product Code HRS

K201578 is an FDA 510(k) premarket notification submitted by Synthes (USA) Products, LLC for the device "DePuy Synthes Variable Angle Locking Patella Plating System". The FDA issued a decision of Substantially Equivalent on September 9, 2020. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Synthes (USA) Products, LLC has at least 10 other 510(k) clearances on record.