New to this company and trying to get my head around it, so (a) sorry if this is a dumb question and (b) thank you in advance to anyone who can set me straight ...
I understand that Remplir has been available for sale in Australia for a number of years, and that there are apparently over 100 orthopedic and plastic surgeons using it, why would Orthocell be required to conduct a study in rats to make its 510(k) submission in the US?
Also, does anyone know which predicate device(s) Orthocell will nominate in its 510(k) submission?
TIA.
Ann: Quarterly Activity Report & Appendix 4C, page-19
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