Spine Wave Announces U.S. FDA's 510K Clearance of the StaXx® IB System, an Intervertebral Body Fusion Device (press release)
The StaXx® IB System Expands the StaXx® Product Portfolio and Offers the Advantage of an Expandable Intervertebral Body Fusion Device With Bone Graft Chambers
SHELTON, CT--(Marketwired - Apr 29, 2013) - Spine Wave, Inc. a privately held medical device company committed to the development and delivery of high-quality innovative medical devices for the treatment of spinal disorders, today announced that it has received 510(k) clearance from the United States Food and Drug Administration 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.
"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 i...
