510(k) K213698

CoLink PCR Plating System by In2bones USA, LLC — Product Code HRS

K213698 is an FDA 510(k) premarket notification submitted by In2bones USA, LLC for the device "CoLink PCR Plating System". The FDA issued a decision of Substantially Equivalent on May 27, 2022. 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.