GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System

GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System is an FDA 510(k)-cleared medical device (K210534) manufactured by Gramercy Extremity Orthopedics, 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 March 25, 2021. Regulation: 8.