510(k) K242751

ARIX Pectus Bar System by Jeil Medical Corporation — Product Code HRS

K242751 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "ARIX Pectus Bar System". The FDA issued a decision of Substantially Equivalent on May 30, 2025. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Jeil Medical Corporation has at least 10 other 510(k) clearances on record.