510(k) K240591

restor3d Kinos Axiom Total Ankle System by Restor3D, Inc. — Product Code HSN

K240591 is an FDA 510(k) premarket notification submitted by Restor3D, Inc. for the device "restor3d Kinos Axiom Total Ankle System". The FDA issued a decision of Substantially Equivalent on April 29, 2024. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. Restor3D, Inc. has at least 10 other 510(k) clearances on record.