510(k) K250933

LORRAINE 2.5/3.5mm Distal Humerus System by Bonebridge AG — Product Code HRS

K250933 is an FDA 510(k) premarket notification submitted by Bonebridge AG for the device "LORRAINE 2.5/3.5mm Distal Humerus System". The FDA issued a decision of Substantially Equivalent on June 11, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Bonebridge AG has at least 9 other 510(k) clearances on record.