Affix IIS Spinous Process Plate System

Affix IIS Spinous Process Plate System is an FDA 510(k)-cleared medical device (K143388) 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 4, 2015. Regulation: 8.