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FDA grants premarket approval for cervical artificial disc

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Globus Medical Inc. announced that the FDA has granted premarket approval for the Secure-C Cervical Artificial Disc.

According to a company press release, the Secure-C is a motion-preserving alternative treatment of neck and arm pain conditions involving disc abnormalities. Designed to provide motion similar to that of the natural cervical spine, the implant is an articulating intervertebral disc replacement comprised of cobalt-chrome endplates and a central polyethylene core and accompanied by specialized instrumentation specifically designed to simplify the surgical procedure.

“We are thrilled not only to receive our first [premarket approval] PMA approval but to bring this excellent technology to the marketplace,” Kelly Baker, PhD, vice president of regulatory and clinical affairs at Globus Medical, stated in the release. “The outstanding clinical performance of the Secure-C has made this PMA well worth the effort and we hope it will be a great benefit to patients.”