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Newmedical Technology, Inc.
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NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR is an FDA 510(k)-cleared medical device (K040064) manufactured by Newmedical Technology, 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 March 22, 2004. Regulation: 8.