510(k) K202912

ARIX Ankle Distal Tibia System by Jeil Medical Corporation — Product Code HRS

K202912 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "ARIX Ankle Distal Tibia System". The FDA issued a decision of Substantially Equivalent on October 29, 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.