510(k) K181528

Austin Miller Large External Fixation System by Austin Miller Trauma, LLC — Product Code KTT

K181528 is an FDA 510(k) premarket notification submitted by Austin Miller Trauma, LLC for the device "Austin Miller Large External Fixation System". The FDA issued a decision of Substantially Equivalent on Feb 28, 2019. 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.