Unison-C Anterior Cervical Fixation System

Unison-C Anterior Cervical Fixation System is an FDA 510(k)-cleared medical device (K170830) manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, 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 June 27, 2017. Regulation: 8.