TranS1 Interbody Fusion System

TranS1 Interbody Fusion System is an FDA 510(k)-cleared medical device (K191791) manufactured by Trans1. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 24, 2019. Regulation: 8.