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Micomed Ortho GmbH
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HALM ZIELKE INSTRUMENTATION SYSTEM is an FDA 510(k)-cleared medical device (K024125) manufactured by Micomed Ortho GmbH. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 21, 2003. Regulation: 8.