Threshold™ V2 Pedicular Fixation System

Threshold™ V2 Pedicular Fixation System is an FDA 510(k)-cleared medical device (K170255) 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 April 13, 2017. Regulation: 8.