Streamline Navigated Instruments

Streamline Navigated Instruments is an FDA 510(k)-cleared medical device (K200095) manufactured by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 25, 2020. Regulation: 8.