PATRIOT COLONIAL Spacer, SUSTAIN Spacer

PATRIOT COLONIAL Spacer, SUSTAIN Spacer is an FDA 510(k)-cleared medical device (K173722) 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 May 22, 2018. Regulation: 8.