VIRTU Lumbar Spacer System

VIRTU Lumbar Spacer System is an FDA 510(k)-cleared medical device (K160699) manufactured by Met 1 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 July 31, 2016. Regulation: 8.