510(k) K162635

Distal Radius Plating System by Miami Device Solutions, LLC — Product Code HRS

K162635 is an FDA 510(k) premarket notification submitted by Miami Device Solutions, LLC for the device "Distal Radius Plating System". The FDA issued a decision of Substantially Equivalent on October 21, 2016. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Miami Device Solutions, LLC has at least 6 other 510(k) clearances on record.