510(k) K242939

ARTFX Trauma Bone Plate and Screw System by Artfx Medical — Product Code HRS

K242939 is an FDA 510(k) premarket notification submitted by Artfx Medical for the device "ARTFX Trauma Bone Plate and Screw System". The FDA issued a decision of Substantially Equivalent on December 23, 2024. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Artfx Medical has at least 4 other 510(k) clearances on record.