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I.T.S. GmbH
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DISTAL ULNA LOCKING PLATE (DUL), ULNA OSTEOTOMY LOCKING PLATE (UOL), 3.0 CANCELLOUS LOCKING SCREW, 3.0 CORTICAL LOCKING is an FDA 510(k)-cleared medical device (K130008) manufactured by I.T.S. 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 June 24, 2013. Regulation: 8.