Cannulated Screw and Kirschner (K wire) System

Cannulated Screw and Kirschner (K wire) System is an FDA 510(k)-cleared medical device (K252758) manufactured by Orthonovis, 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 October 1, 2025. Regulation: 8.