thanks, I had read this about a month ago on the fda website.. last week I asked my OSS about Prodisc maybe being approved thru 510k process.
He said there would need to be at least 3 implants on the market that are FDA approved before one could be compared to this and determined to be "substantially equivalent" and therefore marketable w/o FDA approval.
I didn't see anything to that effect stated on the FDA website...
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