510(k) K213864

Bonebridge Osteosynthesis Plating System by Bonebridge AG — Product Code HRS

K213864 is an FDA 510(k) premarket notification submitted by Bonebridge AG for the device "Bonebridge Osteosynthesis Plating System". The FDA issued a decision of Substantially Equivalent on September 2, 2022. 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.