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Orthohelix Surgical Designs, Inc.
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MAXLOCK EXTREME SYSTEM MODEL MXL is an FDA 510(k)-cleared medical device (K123203) manufactured by Orthohelix Surgical Designs, 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 December 13, 2012. Regulation: 8.