TriMAX Implant System

TriMAX Implant System is an FDA 510(k)-cleared medical device (K190722) manufactured by Crossroads Extemity Systems, 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 August 15, 2019. Regulation: 8.