This is a discussion on FDA Requires New Studies for Movable Spine Supports within the Education, Research and Spine Publications forums, part of the General Spine Discussion Forums category; The FDA has requested manufacturers of dynamic spine stabilization systems to conduct postmarket surveillance studies of fusion rates and other ...
FDA Requires New Studies for Movable Spine Supports The FDA has requested manufacturers of dynamic spine stabilization systems to conduct postmarket surveillance studies of fusion rates and other potential safety hazards.
The order applies to products already available and requires premarket clinical data for new products, which may result in future device labeling changes...
FDA Requires New Studies for Movable Spine Supports (click here for the full article at Medical News Today)
Justin Averna
Founder & President, Spine Patient Society™
www.SpinePatientSociety.org
A 501(c)(3) Tax-Exempt Nonprofit & Charitable Organization
I'm here to help.
- 1994: Football Injury, Severe Hyperextension
- 1997: Snow Skiing Injury
- 3/7/1997: Laminotomy L4/L5
- 1999 & 2003: Motor Vehicle Accidents (not at fault both times) --> Grade V Annular Tears L4/L5 & L5/L6
- 11/15/2003: 2-Level ProDisc® L4/L5 & L5/L6*, *lumbosacral transitional vertebra --> Dr. Rudolf Bertagnoli
- 4/2008: 4.5 years pain-free before "new" leg pain
- 5/14/2009: Dynamic Stabilization System L4/L5, Dr. Rudolf Bertagnoli
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justin (at) spinepatientsociety.org
Disclosure: I have no financial relationships with any surgeons, spine clinics, device manufacturers, pharmaceutical companies, hospitals, etc. -- the SPS Board of Directors serve without compensation.
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