Geo Staple System

Geo Staple System is an FDA 510(k)-cleared medical device (K182212) 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 January 10, 2019. Regulation: 8.