
Dgimed Ortho, Inc.
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DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM is an FDA 510(k)-cleared medical device (K100312) manufactured by Dgimed Ortho, 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 April 19, 2010. Regulation: 8.