510(k) K213905

ONX Large External Fixation System by Orthonovis, Inc. — Product Code KTT

K213905 is an FDA 510(k) premarket notification submitted by Orthonovis, Inc. for the device "ONX Large External Fixation System". The FDA issued a decision of Substantially Equivalent on August 25, 2022. 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. Orthonovis, Inc. has at least 4 other 510(k) clearances on record.