NuVasive® Reline® System

NuVasive® Reline® System is an FDA 510(k)-cleared medical device (K160989) manufactured by Nu Vasive, Incorporated. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 8, 2016. Regulation: 8.