Viking Lumbar Polyaxial Screw System

Viking Lumbar Polyaxial Screw System is an FDA 510(k)-cleared medical device (K180655) manufactured by Presidio Surgical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 12, 2018. Regulation: 8.