Hercules Syndesmosis Implant System

Hercules Syndesmosis Implant System is an FDA 510(k)-cleared medical device (K220260) manufactured by In2bones USA, 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 30, 2022. Regulation: 8.