NILE Alternative Fixation Spinal System

NILE Alternative Fixation Spinal System is an FDA 510(k)-cleared medical device (K160208) manufactured by K2m, 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 March 17, 2016. Regulation: 8.