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Instratek, Inc.
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SUB-TALAR LOK, MODEL 7-11 MM is an FDA 510(k)-cleared medical device (K080280) manufactured by Instratek, 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 13, 2008. Regulation: 8.