510(k) K251892

MAXXOS P.A.C.E. Foot & Ankle Plating System by Maxxos Medical GmbH — Product Code HRS

K251892 is an FDA 510(k) premarket notification submitted by Maxxos Medical GmbH for the device "MAXXOS P.A.C.E. Foot & Ankle Plating System". The FDA issued a decision of Substantially Equivalent on September 8, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030.