Centinel Spine receives IDE approval for 2 prodisc C devices

Alan Condon -  

Centinel Spine received FDA investigational device exemption approval to begin a two-level clinical trial with two separate prodisc C anterior cervical total disc devices.

The trial will compare prodisc C Vivo and prodisc C SK with a total disc replacement device as a control to determine their safety and efficacy.

The objective of the trial will be to compare the two devices with an existing total disc replacement device that is FDA approved for two-level indications. 

"Approval of the prodisc C Vivo and prodisc C SK products in the United States will enable Centinel Spine to provide the widest range of TDR products to surgeons and patients in the world," said John Viscogliosi, chairman and CEO of Centinel Spine.

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