Centinel Spine Gets Clearance for Interbody Fusion Device
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.