NuVaisve® Reline® Cervical System

NuVaisve® Reline® Cervical System is an FDA 510(k)-cleared medical device (K191553) 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 August 13, 2019. Regulation: 8.