
Biomet Trauma
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LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS is an FDA 510(k)-cleared medical device (K081244) manufactured by Biomet Trauma. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 29, 2008. Regulation: 8.