510(k) K243798

Orthex External Fixation System by OrthoPediatrics Corp. — Product Code KTT

K243798 is an FDA 510(k) premarket notification submitted by OrthoPediatrics Corp. for the device "Orthex External Fixation System". The FDA issued a decision of Substantially Equivalent on March 7, 2025. 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. OrthoPediatrics Corp. has at least 10 other 510(k) clearances on record.