510(k) K143385

Acumed Ankle Plating System by Acumed, LLC — Product Code HRS

K143385 is an FDA 510(k) premarket notification submitted by Acumed, LLC for the device "Acumed Ankle Plating System". The FDA issued a decision of Substantially Equivalent on April 6, 2015. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Acumed, LLC has at least 10 other 510(k) clearances on record.