Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System

Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System is an FDA 510(k)-cleared medical device (K162153) manufactured by Ascension Orthopedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 2017. Regulation: 8.