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
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
FDA Documentation