Centinel Spine recently announced EU Medical Device Regulation (MDR) certification for the prodisc C Vivo & prodisc C Nova Cervical Total Disc Replacement (TDR) systems in accordance with the new MDR of the European Union. The devices are now compliant and CE-marked in accordance with the highest European standards of quality, safety, and performance for medical devices.
"The path to MDR approval is extremely challenging. Centinel Spine was willing to push forward and do what was necessary to provide European surgeons with continued access to a proven life-changing technology such as prodisc. As a surgeon, having continued access to prodisc C Vivo & prodisc C Nova into the distant future was extremely important to me and the resulting care that I am able to provide to my patients."
-Prof. Dr. Christoph Mehren, Head of the Spinal Surgery Department at Schön Klinik Hospital in Münich, Germany
Centinel Spine CEO Steve Murray adds, “This marks a pivotal moment for Centinel Spine as an organization. Securing MDR certification for the prodisc C Vivo & prodisc C Nova total disc replacement devices has been a complex and demanding process, but it underscores our commitment to delivering safe, high-quality, and clinically-proven products.”
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