
Allez Spine, LLC
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LAGUNA PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K050060) 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 May 3, 2005. Regulation: 8.