510(k) K260900

DYNEX® External Fixation Systems by Vilex, LLC — Product Code KTT

K260900 is an FDA 510(k) premarket notification submitted by Vilex, LLC for the device "DYNEX® External Fixation Systems". The FDA issued a decision of Substantially Equivalent on April 17, 2026. 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. Vilex, LLC has at least 10 other 510(k) clearances on record.