NuVasive: U.S. FDA grants PMA approval of the PCM Cervical Disc System

theflyonthewall.com

NuVasive announced that the U.S. FDA has granted Premarket Approval for the PCMCervical Disc System. This novel device will be provided to patients and surgeons in the United States as an innovative option to preserve motion in the cervical spine instead of a traditional, motion-eliminating fusion procedure. The FDA approval comes after successful completion of a prospective, multicenter randomized investigational device exemption clinical trial that was conducted at 23 investigational sites across the United States and included 403 total treated patients.

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