ok heres what i found out.from the guy i know at work whom knows some hot shot in the fda.
prodisc failed mfg code 5 10k inspection for tier1 rated device. will be re inspected in 30 to 90 days
once they pass this inspection,offical approval will come in 2 weeks following.
seems this tier1 rating is a prefered insurance rating i suppose meaning more insurance company will pick up the device as standard.
chuck

Any idea how in the hell they could fail an inspection when so much is on the line! Is this common during the appoval process..was it minor any idea if they could fail on a technicality again and be delayed again???? Why isn't the problem being fixed ASAP with an expedited re-inspection. How completely frustrating! I guess I dont really expect any answers, just venting.

all i know it was a type of mgf standard for this tier 1 rating. called 5 10k mfg.
and remember its not a usa company.
probly diff standards {shrug|
chuck

Lovely. Even more waiting for me.....

(could someone please tell me why I didn't select Germany????)

David

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.

I did a quick search on the fda.gov site, did not find anything useful...

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.

Speculation

Gossip

Third Party Information

Don�t get your panties all in a wad

Be patient and have faith in the process that is really all you can do.

LBP,
I thought Prodisc hadn't been FDA approved even at one level yet, talking with person in Dr.Yue's office gave me different impression. So back to previous knowledge re Prodisc FDA approval. OK.
Re 510K, I know what it is, have seen it already on the fda website ~ however my apologies for being at a loss for words describing what it is. Should not have even made attempt in previous reply.
No worries Paulette~ no panty wauds going on here ~reading that gave me a good little laugh~Hanging in there so far~

Agreed about the gossip part. Stil....I hate to hear anything negative, even when it is just (potential) speculation.

I have pretty much decided to through this year out the window, since I am figuring the change of me having two level Prodisc surgery this year is pretty slim.

So, any potential delays at this part just make my overall wait longer.

[bascially, I just like to complain and whine... Just ask anyone who works with me http://adrsupport.org/groupee_common.../icon_wink.gif ]

David