510(k) K192297

APTUS Wrist Arthrodesis Plates by Medartis AG — Product Code HRS

K192297 is an FDA 510(k) premarket notification submitted by Medartis AG for the device "APTUS Wrist Arthrodesis Plates". The FDA issued a decision of Substantially Equivalent on November 8, 2019. 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.