AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM

AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM is an FDA 510(k)-cleared medical device (K133052) manufactured by Nuvasive, Inc.. 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 19, 2013. Regulation: 8.