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New Deal, S.A.
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KALIX II IMPLANT, MODEL 141 0XX WITH XX is an FDA 510(k)-cleared medical device (K053093) manufactured by New Deal, S.A.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 6, 2005. Regulation: 8.