PIONEER SPINOUS PROCESS FUSION PLATE

PIONEER SPINOUS PROCESS FUSION PLATE is an FDA 510(k)-cleared medical device (K101525) 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 October 21, 2010. Regulation: 8.