
Esm Technologies, LLC
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THE TRANSLATION PLATE PHASE 1 (T-1 PLATE) AND PHASE 2 (T-2 PLATE) is an FDA 510(k)-cleared medical device (K072231) manufactured by Esm Technologies, LLC. 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 25, 2007. Regulation: 8.