Centinel receives 510(k) clearance from US FDA for FLX™

Centinel Spine, LLC is pleased to announce that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its FLX™ Platform of Integrated Interbody™ and non-integrated interbody fusion devices. Centinel Spine is the largest privately-held spine company, focused on anterior column reconstruction.

FLX devices are 3D-printed, all-titanium devices which feature a combination of solid and porous radiolucent sections designed to reduce mechanical stiffness and improve visibility, compared to solid titanium implants. The devices also feature a proprietary FUSE-THRU™ trabecular scaffold, designed to allow for bony in-growth and on-growth throughout the implant.

STALIF FLX Integrated Interbody devices offer a unique advantage over other all-titanium implants, as they are indicated for use at one or two contiguous levels with both autograft and/or allogenic bone graft.

The FDA clearance of the FLX platform is the next step in the evolution of Centinel Spine executing on its mission to become the worldwide leading spine company, addressing spinal disease anteriorly with the widest breadth and depth of technology platforms.