
Atlas Spine, Inc.
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APCLO PEDICLE SCREW SYSTEMS is an FDA 510(k)-cleared medical device (K112759) manufactured by Atlas Spine, 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 October 17, 2011. Regulation: 8.