510(k) K202959

PolyLock Plating System by Fusion Orthopedics, LLC — Product Code HRS

K202959 is an FDA 510(k) premarket notification submitted by Fusion Orthopedics, LLC for the device "PolyLock Plating System". The FDA issued a decision of Substantially Equivalent on November 24, 2020. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Fusion Orthopedics, LLC has at least 10 other 510(k) clearances on record.