510(k) K150579

Cardinal Health External Fixation System by Cardinalhealth — Product Code KTT

K150579 is an FDA 510(k) premarket notification submitted by Cardinalhealth for the device "Cardinal Health External Fixation System". The FDA issued a decision of Substantially Equivalent on April 29, 2015. 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. Cardinalhealth has at least 10 other 510(k) clearances on record.