Centinel Spine receives FDA 510(k) clearance for its FLX Platform of 3D-printed all-titanium devices: 4 insights

Surface Technology

Centinel Spine received FDA 510(k) clearance for its FLX Platform of Integrated Interbody and non-integrated interbody fusion devices.

Here are four things to know:

1. The FLX Platform consists of 3D-printed, all-titanium devices with a combination of solid and porous radiolucent sections intended to reduce mechanical stiffness and improve visibility relative to solid titanium implants.

2. The devices feature the proprietary Fuse-Thru trabecular scaffold, which is engineered to allow for bony in-growth and on-growth throughout the implant.

3. Stalif FLX Integrated Interbody devices are indicated for use at one or two contiguous levels with both autograft and/or allogenic bone graft.

4. Centinel Spine is the largest privately-held spine company and is focused on anterior column reconstruction.

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