510(k) K243308

Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) by Bonebridge AG — Product Code HRS

K243308 is an FDA 510(k) premarket notification submitted by Bonebridge AG for the device "Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)". The FDA issued a decision of Substantially Equivalent on December 20, 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.