NuVasive(r) Monolith Corpectomy System

NuVasive(r) Monolith Corpectomy System is an FDA 510(k)-cleared medical device (K170271) 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 March 29, 2017. Regulation: 8.