PROPHECY INVISION Preoperative Navigation Alignment System

PROPHECY INVISION Preoperative Navigation Alignment System is an FDA 510(k)-cleared medical device (K162795) 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 February 21, 2017. Regulation: 8.