510(k) K163650

ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension by Wrightmedicaltechnologyinc — Product Code HRS

K163650 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension". The FDA issued a decision of Substantially Equivalent on Apr 24, 2017. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Wrightmedicaltechnologyinc has 301 other 510(k) clearances on record.