PRECICE UNYTE CoCr System

PRECICE UNYTE CoCr System is an FDA 510(k)-cleared medical device (K162927) manufactured by Nuvasive Specialized Orthopedics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 5, 2017. Regulation: 8.