My understanding is that it works something like this ... the FDA doesn't approve a device for some number of levels, but rather they approve the device within the parameters of the trial. After which any usage of that device outside those parameters is termed "off label". Unless explicitly decreed, "off label" usage is not prohibited by the FDA. But, good luck getting your insurance carrier to cover an "off label" application.
The four level ProDisc I was referring to goes by the handle davidj8121 on this board. He had four lumbar levels done by Dr Zigler at TBI.
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C4/5 - ACDF in 2000
C5/6 - ACDF in 2002
C3/4 & C6/7 - M6 ADR, Nov 2009, Barcelona
Conceded defeat to a manifestly disingenuous BCBS-TX in my quest for reimbursement, Jan 2011
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