Therapy Areas: Devices
Centinel Spine awarded US FDA's marketing clearance for FLX 3D printed all-titanium interbodies
8 June 2018 -

Spine company Centinel Spine LLC reported on Thursday the receipt of the US Food and Drug Administration's (FDA) the 510(k) clearance to market its Integrated Interbody and non-integrated interbody fusion devices for the treatment of degenerative disc disease under its STALIF FLX Platform.

According to the company, the 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 company said the devices feature a proprietary FUSE-THRU trabecular scaffold, designed to allow for bony in-growth and on-growth throughout the implant.

In conjunction, the company's 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.

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