510(k) K192417

ARIX Cannulated Screw System by Jeil Medical Corporation — Product Code HWC

K192417 is an FDA 510(k) premarket notification submitted by Jeil Medical Corporation for the device "ARIX Cannulated Screw System". The FDA issued a decision of Substantially Equivalent on November 26, 2019. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Jeil Medical Corporation has at least 10 other 510(k) clearances on record.