Global Modular Replacement System

Global Modular Replacement System is an FDA 510(k)-cleared medical device (K233261) manufactured by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. 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 7, 2023. Regulation: 8.