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First FDA cervical multilevel indication issued to Centinel Spine

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Centinel Spine Inc. has been granted the first cervical multilevel indication for a Stand-Alone interbody device by the FDA.

According to a company press release, the STALIF C and STALIF C-TI now can be used on-label in multilevel, cervical spine fusion procedures. The STALIF C line was previously indicated for use in allogenic bone graft or autograft at a single level in patients with degenerative disc disease of the cervical spine. An integrated interbody, the dynamic capability of the STALIF C-Ti screws allow the vertebral bodies to settle onto to the graft site.

“This is a valuable indication given the high incidence of multilevel degenerative disc disease in the cervical spine,” John J. Viscogliosi, chairman and chief executive officer of Centinel Spine, stated in the release. “We are excited to be the first company to receive this indication and to offer this benefit to our surgeon customers and their patients. This first-to-market indication is evidence that Centinel Spine will continue to be on the forefront of developing and enhancing spinal devices to meet the needs of our surgeon customers and their patients.”

Reference: www.centinelspine.com