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FDA approves Spine Wave intervertebral body fusion device

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Spine Wave's intervertebral body fusion device.

Producing expandable PEEK spacers, the StaXx IB system will now for the first time offer an expandable device with bone graft chambers, claims the company.

Spine Wave chief technology officer John Pafford said the company is pleased to be able to offer the StaXx IB System as the latest product in its new and highly differentiated portfolio of technologies.

"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," Pafford added.

The company said it will display the device at the American Academy of Neurosurgeons meeting in New Orleans, US.