SYNTHES IN-SITU BENDER/CUTTER

SYNTHES IN-SITU BENDER/CUTTER is an FDA 510(k)-cleared medical device (K021458) 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 July 23, 2002. Regulation: 8.