SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM

SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM is an FDA 510(k)-cleared medical device (K972516) manufactured by Synthes (Usa). This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 1997. Regulation: 8.