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AMDT Gains FDA Clearance for SixFix Hexapod External Fixator -

AMDT Holdings was granted FDA 510(k) clearance to market the SixFix™ hexapod fixator device along with its SixFix deformity analysis and correction software (DACS) application. The six struts of the device are pre-assembled in one compact unit. The assembly unfolds to connect to the rings and provides a full range of lengths with a single strut design. The strut assembly design can extend to 300mm in length, offering an alternative that simplifies inventory and saves time. The device can be sterile packaged for ease of storage and portability. Used with SixFix DACS software, the system can streamline the time and effort required to generate a prescription detailing the strut adjustments necessary to correct a deformity. DACS reduces surgeon input to one numerical value and two graphical variables that are established with a few clicks of the mouse. (AMDT Holdings, Inc., 5/16/19)