510(k) K240318

SITTER 3.5mm Versatile System by Bonebridge AG — Product Code HRS

K240318 is an FDA 510(k) premarket notification submitted by Bonebridge AG for the device "SITTER 3.5mm Versatile System". The FDA issued a decision of Substantially Equivalent on August 23, 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.