PATRIOT® Lumbar Spacers, SUSTAIN® Spacers

PATRIOT® Lumbar Spacers, SUSTAIN® Spacers is an FDA 510(k)-cleared medical device (K181357) manufactured by Globus Medical, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 5, 2018. Regulation: 8.