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Newdeal Sas
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PANTA NAIL (DIA. 10MM), PANTA NAIL XL is an FDA 510(k)-cleared medical device (K091788) 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 July 28, 2009. Regulation: 8.