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Orthonetx, Inc.
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GENEROS SB SMALL BONE DISTRACTION IMPLANT is an FDA 510(k)-cleared medical device (K051162) manufactured by Orthonetx, 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 July 18, 2005. Regulation: 8.