510(k) K173121

Ankle Fusion Plating System by In2bones Sas — Product Code HRS

K173121 is an FDA 510(k) premarket notification submitted by In2bones Sas for the device "Ankle Fusion Plating System". The FDA issued a decision of Substantially Equivalent on November 28, 2017. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. In2bones Sas has at least 10 other 510(k) clearances on record.