510(k) K193616

ARIX Ankle System by Jeil Medical Corporation — Product Code HRS

K193616 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "ARIX Ankle System". The FDA issued a decision of Substantially Equivalent on March 4, 2020. 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.