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Centinel Spine receives FDA 510(k) clearance for 3D-printed all-titanium interbody devices

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Centinel Spine LLC announced it received FDA 510(k) clearance for the FLX platform of integrated interbody and non-integrated interbody fusion devices.

“We are excited to announce the clearance of the FLX Platform, which represents the next evolution in STALIF technology,” John Viscogliosi, Centinel Spine chairman and CEO, said in a company press release. “Utilizing 3D-printing, we are able to offer the proven benefits of the STALIF design in a truly novel, all-titanium lattice option. This allows our surgeons the flexibility to use multiple implant material options through a single set of instruments to address each patient’s unique pathology.”

According to the release, the FLX devices are 3D-printed, all-titanium devices that include a combination of solid and porous radiolucent sections intended to reduce mechanical stiffness and improve visibility. The devices include the company’s FUSE-THRU trabecular scaffold for bony in-growth and on-growth throughout the implant. The STALIF FLX integrated interbody devices are intended to be used at one or two contiguous levels with autograft and/or allogenic bone graft.

Reference:

www.centinelspine.com