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Added sizes of Aurora Spine ZIP ULTRA and ZIP MIS Systems get FDA 510(k) clearance
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Aurora Spine Corporation announced it has received FDA 510(k) clearance for additional sizes of its sterile-packed ZIP ULTRA Minimally Invasive Interspinous Fusion System and of its new sterile-packed ZIP MIS system.
The additional ZIP ULTRA sizes of 35 mm and 40 mm were recently cleared, according to a company press release and they expand the company's growing portfolio to better conform to patient anatomy.
The additional sizes have already been used in surgeries in Europe under the company's CE Mark approval there.
“The receipt of these additional FDA 510(k) clearances for our ZIP Ultra and ZIP MIS Interspinous Fusion System is another key milestone for Aurora Spine and allows us to expand our spinal product portfolio in the U.S. and key global markets. This achievement is a testament to the ongoing dedication and perseverance of our team," Trent J. Northcutt, president and chief executive officer of Aurora Spine, stated in the release. "I am delighted we have obtained additional FDA clearances, especially given the overwhelming response for the ZIP devices. The success of our screw-less spine procedure is a testament to our laser focus on disruptive technology and our commitment to 'Simplifying the Complex'."
The ZIP product features non-articulating bone anchors, Aurora Spine's patent pending one-step locking mechanism with no set screw and a large graft space designed for biologic material. With this added FDA clearance for the ZIP product in all three sizes — 35 mm, 40 mm and 45mm — the line will be available at the end of the third quarter of 2014, as noted in the release.