ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System

ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System is an FDA 510(k)-cleared medical device (K180980) manufactured by Camber Spine Technologies, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 2018. Regulation: 8.