INTEGRA EXTERNAL FIXATION SYSTEM

INTEGRA EXTERNAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K140463) manufactured by Ascension Orthopedic. 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 9, 2014. Regulation: 8.