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Pioneer Surgical Technology, Inc.
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PIONEER CROSSFUSE II IBF/VBR SYSTEM is an FDA 510(k)-cleared medical device (K112496) 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 September 27, 2011. Regulation: 8.