AXI+LINE Proximal Bunion Correction System

AXI+LINE Proximal Bunion Correction System is an FDA 510(k)-cleared medical device (K152548) manufactured by Nextremity Solutions, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 20, 2015. Regulation: 8.