COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS

COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS is an FDA 510(k)-cleared medical device (K173115) 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 19, 2017. Regulation: 8.