Streamline MIS Spinal Fixation System

Streamline MIS Spinal Fixation System is an FDA 510(k)-cleared medical device (K192396) manufactured by Pioneer Surgical Technology, 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 November 25, 2019. Regulation: 8.