PRECICE UNYTE System

PRECICE UNYTE System is an FDA 510(k)-cleared medical device (K172061) 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 August 23, 2017. Regulation: 8.