
Pioneer Surgical Technology
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QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES is an FDA 510(k)-cleared medical device (K093692) manufactured by Pioneer Surgical Technology. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 10, 2010. Regulation: 8.