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Allez Spine, LLC
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LAGUNA SIZE 8 PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K091995) manufactured by Allez Spine, LLC. 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 6, 2009. Regulation: 8.