510(k) K193543

CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System by In2bones USA, LLC — Product Code HRS

K193543 is an FDA 510(k) premarket notification submitted by In2bones USA, LLC for the device "CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System". The FDA issued a decision of Substantially Equivalent on January 17, 2020. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. In2bones USA, LLC has at least 10 other 510(k) clearances on record.