Centinel Spine® announced 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.
This 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," Centinel Spine CEO Steve Murray said. "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.”
Centinel Spine's leadership in anterior column reconstruction was strengthened in late 2017 through the acquisition of the prodisc Total Disc Replacement technology platform.