Kalitec Direct InSePtion™ MIS Fixation System

Kalitec Direct InSePtion™ MIS Fixation System is an FDA 510(k)-cleared medical device (K163471) manufactured by Kalitec Direct, 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 15, 2017. Regulation: 8.