NuVasive Reline Fenestrated Screws, High V+ Bone Cement

NuVasive Reline Fenestrated Screws, High V+ Bone Cement is an FDA 510(k)-cleared medical device (K180498) 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 November 27, 2018. Regulation: 8.