510(k) K241387

CoLink NeoFuse MIS Plating System (see attached parts list) by In2bones USA — Product Code HRS

K241387 is an FDA 510(k) premarket notification submitted by In2bones USA for the device "CoLink NeoFuse MIS Plating System (see attached parts list)". The FDA issued a decision of Substantially Equivalent on August 13, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. In2bones USA has at least 10 other 510(k) clearances on record.