NuVasive NuvaLine Mobile App

NuVasive NuvaLine Mobile App is an FDA 510(k)-cleared medical device (K162647) manufactured by Nu Vasive, Incorporated. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 30, 2017. Regulation: 8.