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.
Halma acquires Rovers Medical Devices
boston Scientific granted FDA approval for AGENT Drug-Coated Balloon
Enable Injections names new chief operating officer
BridgeBio Pharma and Kyowa Kirin partner on infigratinib for skeletal dysplasias in Japan
Redwood Scientific signs agreement with Jeeva Clinical Trials
Tissue Regenix ships first allograft products in the EU post-HPRA approval
Kromek secures GBP1.3m grant for AI-powered radiation sensor project