NuVasive® VersaTie System

NuVasive® VersaTie System is an FDA 510(k)-cleared medical device (K161265) 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 July 14, 2016. Regulation: 8.