HANSEN-STREET TYPE INTRAMEDULLARY NAIL

HANSEN-STREET TYPE INTRAMEDULLARY NAIL is an FDA 510(k)-cleared medical device (K905348) manufactured by O'Tec Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 10, 1990. Regulation: 8.