Mariaa,

there's some confusion because of the wording. The FDA sent the manufac of ProDisc an "approvable letter" but that doesn't mean it's approved as in ready to use on patients yet. The final approval for use on public at ONE level is still pending some inspections and other stuff. So you cannot have a one level ProDisc yet. That is what we are all whining about....chasswen is saying that his connection said ProDisc has failed some inspection standards which will force us to wait longer than hoped and expected. We are not even talking about the 2 level yet. That is a separate arm of the clinical trials that is supposed to be approved sometime (months) after the one level is finally approved.

FYI: 510K is a reference to a section of the law regulating medical devices.