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Orthofix, Inc.
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GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) is an FDA 510(k)-cleared medical device (K110805) manufactured by Orthofix, 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 June 20, 2011. Regulation: 8.