SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS

SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS is an FDA 510(k)-cleared medical device (K130478) 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 July 25, 2013. Regulation: 8.