510(k) K193554

APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System by Medartis AG — Product Code HRS

K193554 is an FDA 510(k) premarket notification submitted by Medartis AG for the device "APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System". The FDA issued a decision of Substantially Equivalent on February 16, 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.