510(k) K221787

Auxein's DHS/DCS Plate System by Auxein Medical Private Limited — Product Code KTT

K221787 is an FDA 510(k) premarket notification submitted by Auxein Medical Private Limited for the device "Auxein's DHS/DCS Plate System". The FDA issued a decision of Substantially Equivalent on November 30, 2023. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. Auxein Medical Private Limited has at least 10 other 510(k) clearances on record.