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Frontier Medical Devices, Inc.
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FRONTIER SADL INTERBODY FUSION DEVICE is an FDA 510(k)-cleared medical device (K112700) manufactured by Frontier Medical Devices, 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 October 31, 2012. Regulation: 8.