HALF DOME Posterior Lumbar Interbody System

HALF DOME Posterior Lumbar Interbody System is an FDA 510(k)-cleared medical device (K182877) manufactured by Astura Medical, 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 May 2, 2019. Regulation: 8.