NuVasive® Reline® 4.5-5.0 System

NuVasive® Reline® 4.5-5.0 System is an FDA 510(k)-cleared medical device (K190636) 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 October 18, 2019. Regulation: 8.