Home » Centinel Spine Gets Clearance for Interbody Fusion Device
Centinel Spine Gets Clearance for Interbody Fusion Device
Devices Submissions and Approvals
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.