Tigon Medical Fractures, Instability, and Reconstruction (FIRE)

Tigon Medical Fractures, Instability, and Reconstruction (FIRE) is an FDA 510(k)-cleared medical device (K240175) manufactured by Tigon Medical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 28, 2024. Regulation: 8.