NuVasive Receives Expanded FDA 510(k) Clearance for TLX Interbody System

By Julie A. Vetalice

NuVasive received expanded FDA 510(k) clearance of the TLX™ interbody fusion system, including an expandable 20° cage, use with allogeneic bone graft and use in additional levels of the spine.

Prior to the new clearance, TLX interbodies were available in 15° lordotic options and only indicated for use with allograft. New levels include use in the thoracic spine and at the thoracolumbar junction to treat disc degeneration or degenerative spondylolisthesis at one or two adjacent levels. Finally, use as an adjunct to fusion in multilevel degenerative scoliosis is now also cleared.

TLX can be used with Integrated Global Alignment® (iGA) software for calculation of alignment parameters, pre-operatively.

Source: NuVasive, Inc.

 

 

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory