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| iSpine Discuss An Open Letter To Spine Surgeons in the Main forums forums; Originally Posted by Maria ADR seeker This is nice and low key for you while still being direct enough to ... |
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I did get a call from a surgeon in Chapel Hill who was involved in the clinical trials for Neo Disk. He did 14 of them and only one failed and he was honest enough to admit is was his fault. He used the wrong size implant. Neo Disk is still not available and Spinal Kenetics has no plans to seek FDA approval for the M6. The FDA has gotten worse under Commissioner Margaret Hamburg MD. She is now stacking the advisory panels with paid industry shills. You can contact the FDA to oppose the new draft guidance by writing to: Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 10-61 Rockville, MD 20857 Or calling: (888) 463-6332 Be sure to reference Docket No. FDA-1999-D-0792 To contact FDA Commissioner Margaret Hamburg directly, you can call her: (301) 796-5000 Or email her: Office: Margaret.Hamburg@fda.hhs.gov Personal: margaretahamburg@aol.com You can also contact your representatives by visiting: Congress.org - Get informed, get involved |
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