510(k) K162032

Arrowhead Mini-Rail Fixator by Arrowhead De, LLC — Product Code KTT

K162032 is an FDA 510(k) premarket notification submitted by Arrowhead De, LLC for the device "Arrowhead Mini-Rail Fixator". The FDA issued a decision of Substantially Equivalent on February 21, 2017. 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. Arrowhead De, LLC has at least 2 other 510(k) clearances on record.