
Synthes (Usa), LLC
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SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM is an FDA 510(k)-cleared medical device (K130146) manufactured by Synthes (Usa), LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 19, 2013. Regulation: 8.