Medical Devices

U.S. FDA grants 510(k) clearance to market expandable spine device in U.S.

Published in Medical Letter on the CDC and FDA, May 31st, 2006

Spine Wave announced that the company received U.S. Food and Drug Administration (FDA) 510(k) clearance to market the StaXx XD expandable device. The expandable PEEK spacer, indicated for use as a vertebral body replacement device, will be the first commercial product that the company will release into the U.S. market.

Spine Wave expects to complete a StaXx XD limited U.S. release this summer with a broad market launch in the fall.

In January, Spine Wave closed a series C financing and raised an additional $36.5 million, bringing the total funds raised to date to $90 million.

The company is focused on the development and marketing...

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Source: Medical Letter on the CDC and FDA (2006-05-31)

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