
Newdeal Sas
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NEWDEAL TIBIAXYS SYSTEM is an FDA 510(k)-cleared medical device (K073375) manufactured by Newdeal Sas. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 20, 2008. Regulation: 8.