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Paradigm Spine, LLC
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PARADIGM INTERSPINOUS FUSION PLATE is an FDA 510(k)-cleared medical device (K093438) manufactured by Paradigm 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 October 5, 2010. Regulation: 8.