510(k) K161417

DePuy Synthes MAXFRAME Multi-Axial Correction System by Synthes USA, LLC — Product Code KTT

K161417 is an FDA 510(k) premarket notification submitted by Synthes USA, LLC for the device "DePuy Synthes MAXFRAME Multi-Axial Correction System". The FDA issued a decision of Substantially Equivalent on November 10, 2016. 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. Synthes USA, LLC has at least 10 other 510(k) clearances on record.