FDA Documentation

[iSpine-Admin]

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Food and Drug Administration:

• Results of the prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement versus circumferential fusion for the treatment of 1-level degenerative disc disease
• A prospective, randomized, multicenter food and drug administration Investigational device exemptions study of lumbar total disc replacement with the CHARITE (TM) artificial disc versus lumbar fusion Part I: Evaluation of clinical outcomes
• Revisability of the CHARITE artificial disc replacement: analysis of 688 patients enrolled in the U.S. IDE study of the CHARITE Artificial Disc