M-6 in the U.S.
Someone may have more current info., but last I heard, about a year ago, Spinal Kenetics had decided not to seek FDA approval for use of the M-6 in the U.S. due to the cost and length of the approval process. Since they already have a strong oversees market they were just going to stay with marketing its use outside the U.S.?
JPJH
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11/13/10 M-6 ADR C 4/5 & 5/6. Dr. Pablo Clavel
01/15/2008 Evaluated via MRI UCSF Spine Center. Recommended sinlge level C 4/5 ADR with Pro Disc or fusion. 02/23/10 Evaluated via MRI UCSF Spine Center. Recommended two level C 4/5 & 5/6 ADR with Pro Disc or fusion. ADR denied by BC. Appealed, lost two appeals. Patient refused fusion.
2005-2008 Unknown cause of spinal stenosis at C 4/5.
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