Centinel Spine announces approval for the manufacturing transfer of prodisc technology

Centinel’s prodisc C & prodisc L devices

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

The FDA approval for manufacturing transfer is a critical milestone for Centinel Spine as it allows the company to better manage its prodisc supply chain and associated costs, the company said in a press release.

The manufacturing transfer and site change was an extensive two-year process requiring FDA inspection audits at Centinel Spine-associated prodisc manufacturing sites along with approval of a PMA supplement by the FDA.

“This approval is a major achievement by the company, thanks to a complete team effort by many involved,” stated Centinel Spine CEO Steve Murray. “The team executed a well-designed plan that included three FDA 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,” Murray concluded.


Please enter your comment!
Please enter your name here