Threshold Pedicular Fixation System, Palisade Pedicular Fixation System

Threshold Pedicular Fixation System, Palisade Pedicular Fixation System is an FDA 510(k)-cleared medical device (K160980) manufactured by Spineology, 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 May 25, 2016. Regulation: 8.