510(k) K261351

SALGINA 2.5mm Distal Radius System by Bonebridge AG — Product Code HRS

K261351 is an FDA 510(k) premarket notification submitted by Bonebridge AG for the device "SALGINA 2.5mm Distal Radius System". The FDA issued a decision of Substantially Equivalent on June 26, 2026. 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.