510(k) K201259

ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System by Wrightmedicaltechnologyinc — Product Code HRS

K201259 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System". The FDA issued a decision of Substantially Equivalent on January 8, 2021. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.