510(k) K252826

ARIX Femur Nail System by Jeil Medical Corporation — Product Code HSB

K252826 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "ARIX Femur Nail System". The FDA issued a decision of Substantially Equivalent on December 10, 2025. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Jeil Medical Corporation has at least 10 other 510(k) clearances on record.