510(k) K261154

CoLink® & CoLag® Non-Sterile Screws by In2Bones USA, LLC — Product Code HWC

K261154 is an FDA 510(k) premarket notification submitted by In2Bones USA, LLC for the device "CoLink® & CoLag® Non-Sterile Screws". The FDA issued a decision of Substantially Equivalent on May 30, 2026. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. In2Bones USA, LLC has at least 10 other 510(k) clearances on record.