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November 9, 2006
Medtronic Sofamor Danek
Portions of this document have been determined to be exempt
from disclosure under the Freedom of Information Act (the
FOIA) (5 U.S.C. §552). These redacted portions will appear
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Summary of Safety and Effectiveness Data
The statements contained in this document(s) are those of
the product's sponsor, not FDA, and FDA does not necessarily
agree with the sponsor's statements. FDA has not made a final
determination about the safety or effectiveness of the product
described in this document.