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.