SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)

SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN) is an FDA 510(k)-cleared medical device (K992348) 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 22, 1999. Regulation: 8.