FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM

FX-CABLELOK(TM) STOP(TROCHANTER HOOK) SYSTEM is an FDA 510(k)-cleared medical device (K935646) manufactured by Biodynamic Technologies, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 8, 1994. Regulation: 8.