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Medical Devices / Submissions and Approvals

Centinel Spine Gets Clearance for Interbody Fusion Device

June 11, 2018
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The FDA granted Centinel Spine 510(k) clearance to market its FLX platform of integrated and non-integrated interbody fusion devices.

The 3D printed titanium devices  feature porous radiolucent sections to reduce mechanical stiffness and improve visibility compared with solid titanium implants.

The devices also have a proprietary trabecular scaffold that allows for bony in-growth and on-growth throughout the implant. They are indicated for use at one or two contiguous levels with both autograft and/or allogenic bone graft.

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