510(k) K210060

CoLink Mfx Implant System by In2bones USA, LLC — Product Code HRS

K210060 is an FDA 510(k) premarket notification submitted by In2bones USA, LLC for the device "CoLink Mfx Implant System". The FDA issued a decision of Substantially Equivalent on March 12, 2021. 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.