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Extensive and ongoing training in how to use and interpret data is regulated. "yet another knee implant", or do you want them thinking "reproducible surgical technique" or "happy patients, returning to their normal, active lifestyle. The question pertains to approval in Europe, Australia, Japan, Canada and how that relates to a US approval, and secondly, what type of 510(k) to prepare in the US.  my blog post:  http://www.webinarjammemberarea.com/