COROENT STERILE IMPLANTS SYSTEM

COROENT STERILE IMPLANTS SYSTEM is an FDA 510(k)-cleared medical device (K132601) 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 December 23, 2013. Regulation: 8.