510(k) K193633

APTUS® Ankle Trauma System 2.8/3.5 by Medartis AG — Product Code HRS

K193633 is an FDA 510(k) premarket notification submitted by Medartis AG for the device "APTUS® Ankle Trauma System 2.8/3.5". The FDA issued a decision of Substantially Equivalent on March 26, 2020. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Medartis AG has at least 10 other 510(k) clearances on record.