Palladian Lumbar Pedicle Screw System

Palladian Lumbar Pedicle Screw System is an FDA 510(k)-cleared medical device (K143230) manufactured by Neurostructures, 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 February 24, 2015. Regulation: 8.