Aurora Spine Receives CE Marking
Online, July 25, 2013 (Newswire.com) - Aurora Spine has now received the CE Mark Approval for its ZIP™ MIS Interspinous Fusion System. The CE mark designation will allow the ZIP™ MIS system to be sold in the European Union and other countries that recognize or require this approval. Aurora Spine's product officially complies with the applicable safety legislation in the EU market.
"The ZIP™ MIS Interspinous Fusion System is the first device with the unique ZIP-LOCK technology to provide simple stabilization of the spine for spinal surgery. We are very excited about the CE Mark approval and that now we are able to make this distinctive implant available to patients and surgeons all over Europe" said Laszlo Garamszegi, Chief Technology Officer of Aurora Spine.
The Aurora Spine Zip™ MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine Zip™ MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.
"This is a very significant accomplishment for the company as it moves toward commercialization and its planned launch into the European markets." stated Trent Northcutt, President and CEO of Aurora Spine. "The CE Mark also paves the way for approvals of the ZIP™ MIS Interspinous Fusion System device internationally, meeting the company's global mandate".
Aurora Spine specializes in minimally-invasive (MIS), regenerative technologies. Our mission is to be the leader in advanced spinal innovations which will have a positive impact on lives worldwide.
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