Prodisc™-C - FDA docs: Approval Order 12/17/07, Summary of Safety, Effectiveness Data

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FDA (Food & Drug Administration)
Center for Devices and Radiological Health:
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Link ProDisc™-C Total Disc Replacement - P070001
Link ProDisc™-C Approval Order
Link ProDisc™-C Consumer Information

Link ProDisc™-C Summary of Safety and Effectiveness Data
Link ProDisc™-C Labeling[/list]

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The hard data on Prodisc-C ( Cervical ADR . TDR . TDA ) compared to ACDF ( Fusion )<UL TYPE=SQUARE>Adverse Events,
Secondary Surgical Procedures - Index Level,
Summary of Non-Clinical Laboratory Studies,
...,[/list]last two documents.

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