FDA 510K Clearance For Spine Wave’s StaXx® IB System

In short

Spinal device company Spine Wave, Inc.has received US FDA 510(k) clearance to market and sell the StaXx® IB System, an Intervertebral Body Fusion Device.


The StaXx® IB System leverages Spine Wave’s well established ability to produce expandable PEEK spacers and now for the first time offers an expandable device with bone graft chambers.

The Company will be previewing the device at the American Academy of Neurosurgeons meeting in New Orleans.

Company comments

“We are pleased to be able to offer the StaXx® IB System as the latest product in our innovative and highly differentiated portfolio of technologies,” said John Pafford, Spine Wave Chief Technology Officer. “This is the first of several exciting products we expect to introduce over the next twelve months as we strive to deliver important and novel clinical solutions for spine surgeons.”

Source: Spine Wave, Inc., MarketWired