AXIS 5.5 Lumbar Pedicle Screw System

AXIS 5.5 Lumbar Pedicle Screw System is an FDA 510(k)-cleared medical device (K180301) manufactured by Axis Orthopaedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 9, 2018. Regulation: 8.