TranS1 AxiaLIF Plus System

TranS1 AxiaLIF Plus System is an FDA 510(k)-cleared medical device (K192792) manufactured by Trans1. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 2019. Regulation: 8.