HALF DOME Posterior Lumbar Interbody System

HALF DOME Posterior Lumbar Interbody System is an FDA 510(k)-cleared medical device (K172947) manufactured by Astura Medical. 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 17, 2018. Regulation: 8.