Geminus Volar Distal Radius Plating System

Geminus Volar Distal Radius Plating System is an FDA 510(k)-cleared medical device (K252949) manufactured by Skeletal Dynamics, 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 November 12, 2025. Regulation: 8.