Centinel Spine® has obtained MDR Certification for its Cervical Total Disc Replacement Systems

(West Chester, PA) Centinel Spine has secured EU Medical Device Regulation (MDR) certification for its prodisc C Vivo and prodisc C Nova Cervical Total Disc Replacement systems. This certification meets the highest European standards for medical devices ensuring quality safety and performance. The prodisc C Vivo and prodisc C Nova are the first and only cervical TDR system with two different MDR-certified devices. Both devices have been in international clinical use since 2009.

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 and 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. A fundamental pillar of our strategic vision is to improve the lives of as many patients as possible worldwide by expanding access to prodisc technologies. Achieving MDR certification represents a critical milestone in realizing that vision."

The prodisc C Vivo features a keel-less design for immediate fixation. The prodisc C Nova has a flat endplate and a tri-keel design for immediate fixation. Both devices use prodisc CORE technology which has been used in over 275000 implantations. A German surgeon Prof. Dr. Christoph Mehren notes the importance of continued access to the prodisc technologies. 

SOURCE Centinel Spine, LLC