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I.T.S. Implantat-Technologie-Systeme GmbH
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FR.O.H. CALCANEUS REPAIR SYSTEM is an FDA 510(k)-cleared medical device (K051642) manufactured by I.T.S. Implantat-Technologie-Systeme 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 August 21, 2005. Regulation: 8.