SALVATION(R) External Fixation System

SALVATION(R) External Fixation System is an FDA 510(k)-cleared medical device (K153635) manufactured by Wrightmedicaltechnologyinc. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 12, 2016. Regulation: 8.