Centinel gets 1st FDA clearance for cervical multilevel indication — 5 key notes

The Food and Drug Administration granted Centinel Spine the cervical multilevel indication for the STALIF C and STALIF C-Ti integrated interbody device.

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Here are five things to know:

 

1. This is the first cervical multilevel indication for a stand-alone interbody device.

 

2. The STALIF C was previously cleared for use in conjunction with autograft or allogeneic bone graft at a single level for patients with degenerative disc disease. The new indication expands indications for multilevel cervical spinal fusion procedures.

 

3. The STALIF C-Ti screws are designed for the vertebral bodies to settle onto the graft site. The screws have a compressive lag fixation and osteoconductive titanium coating.

 

4. The device is used for patients with degenerative disc disease in the cervical spine.

 

5. Centinel Spine is a privately-held spinal device company focused on standalone, no-profile integrated interbody fusion technologies.

 

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