NuVasive Gains FDA Clearance for Thoracolumbar Interbodies

By Julie A. Vetalice

NuVasive Gains FDA Clearance for Thoracolumbar Interbodies

NuVasive received FDA 510(k) clearance for its thoracolumbar interbody portfolio to include the treatment of multi-level sagittal deformities in the thoracolumbar spine. This clearance expands the portfolio's indications from one- to two-level spine surgery, to now multiple levels.

NuVasive's thoracolumbar portfolio of static and expandable interbody implants, Cohere®, Modulus®, TLX®, MLX® and CoRoent®, are available in a variety of dimensions to suit specific patient needs. These implants procedurally integrate with NuVasive's enabling technologies, including:

  • Integrated Global Alignment® (iGA®), comprising surgical planning tools NuvaLine® and NuvaMap® O.R.
  • Bendini® digital spinal rod bending system to create patient-specific rods

"NuVasive's thoracolumbar interbodies are now the only implants on the market to be clinically validated in and indicated for the treatment of sagittal deformities," said Massimo Calafiore, Executive Vice President, Global Business Units at NuVasive. "This clearance is reflective of NuVasive's leadership in the field of global spinal alignment, and reflects the Company's commitment to providing procedural solutions that help improve patient outcomes through the preservation and restoration of sagittal alignment."

Product Labels: Lumbar Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory