ARx MIS Spinal Screw System

ARx MIS Spinal Screw System is an FDA 510(k)-cleared medical device (K233455) manufactured by Life Spine, 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 11, 2023. Regulation: 8.