510(k) K210157

SOLE Medial Column Fusion Plate by Orthofix Srl — Product Code HRS

K210157 is an FDA 510(k) premarket notification submitted by Orthofix Srl for the device "SOLE Medial Column Fusion Plate". The FDA issued a decision of Substantially Equivalent on April 20, 2021. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Orthofix Srl has at least 10 other 510(k) clearances on record.