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May 28, 2020

Centinel Spine receives FDA approval for transfer of prodisc systems

Centinel Spine has received the US Food and Drug Administration (FDA) approval for the manufacturing transfer of the prodisc C Cervical Total Disc Replacement and prodisc L Lumbar Total Disc Replacement systems to new strategic vendors.

Centinel Spine has received the US F ood and Drug Administration (F DA) approval for the manufacturing transfer of the prodisc C Cervical Total Disc Replacement and prodisc L Lumbar Total Disc Replacement systems to new strategic vendors.

The company obtained the approval following an extensive two-year process, involving F DA inspection audits at its prodisc manufacturing sites along with the approval of a PMA supplement by the agency.

According to the company, the approval will enable it to better manage its prodisc supply chain and associated costs.

Centinel Spine CEO Steve Murray said: “This approval is a major achievement by the company, thanks to a complete team effort by many involved.

“The team executed a well-designed plan that included three F DA facility audits, resulting in zero non-conformances or observations. The approval provides the company with control of prodisc manufacturing as we continue to advance both the prodisc cervical and prodisc lumbar systems.”

The company has a good presence in anterior column reconstruction since the acquisition of the prodisc Total Disc Replacement technology platform in 2017.

Centinel Spine is considered to be the only company with F DA-approved cervical and lumbar total disc replacement devices.

The company recently obtained F DA approval for two-level indications for the prodisc L Lumbar Total Disc Replacement system.

It has also initiated clinical trial comparing the prodisc C Vivo and prodisc C SK devices with an approved cervical TDR product as a control to validate their safety and effectiveness in an F DA IDE study.

The company started its operations in 2008 through the merger-acquisition of Raymedica and Surgicraft medical companies.

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