Tuesday, January 23, 2018 7:54:50 AM
https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150776.pdf
Go to the predicate device comparison starting on page 12 (labeled as page 9 of the application). Looking at the factors they have taken into consideration, and considering how SPORT will stack up when compared to other devices which are already out there, our 510K just might be a slam dunk when the time comes. And the Medrobotic Flex system now might be on our list of predicate devices as well, given the new approval for more indications.
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