
Applied Spine Technologies, Inc.
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BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020 is an FDA 510(k)-cleared medical device (K061162) manufactured by Applied Spine Technologies, 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 July 25, 2006. Regulation: 8.