510(k) K242399

Bonebridge Osteosynthesis Plating System by Bonebridge AG — Product Code HRS

K242399 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 October 31, 2024. 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.