The 510K I believe is something that means Prodisc would pass review because it's a similar implant(to one that is already FDA approved) therefore not need to go thru additional FDA type of whatever.. I've forgotten exactly the wording obviously tho this can be looked up easily enough at the fda website.
What I was told by Dr.Yue's office several days ago is that one level Pro disc was FDA approved back in Jan and that what is going to be approved next is the use of Pro disc for 2 level or multilevel implant.
So conceivably if this were true, if the surgeon I saw most recently is requesting to perform a one level ADR with Prodisc and one level fusion which he is, that could conceivably be approved. But if he is requesting authorization for 2 level ADR with Prodisc, it would be non certified or denied again.
I think just to make sure, I'll visit the fda website to see what is stated there, if anything to date re Prodisc.
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