510(k) K203698

CoLink Sfx Implant System by In2bones USA, LLC — Product Code HTY

K203698 is an FDA 510(k) premarket notification submitted by In2bones USA, LLC for the device "CoLink Sfx Implant System". The FDA issued a decision of Substantially Equivalent on May 4, 2021. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. In2bones USA, LLC has at least 10 other 510(k) clearances on record.