Aurora Spine Receives FDA 510(k) Clearance for Pre-Packaged Sterile ZIP 51™ MIS Interspinous Fixation Implant
Aurora Spine Corporation (TSX VENTURE:ASG) announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ZIP 51™, Aurora Spine's slimmest minimally invasive interspinous fixation implant for spinal fusion.
The ZIP 51 was developed as an alternative to pedicle screw fixation and designed for stabilization and load sharing during the TI-S1 thoracolumbar fusion procedures. ZIP 51 is also intended to be an adjunct to interbody fusion, specifically for the treatment of degenerative disc disease, spondylolisthesis, trauma, and/or tumor.
"Aurora is changing spine surgery, and we are thrilled to receive FDA clearance with the ZIP 51, another key product in the Aurora Spine MIS Fusion System," said Trent J. Northcutt, President and CEO of Aurora Spine. "The new ZIP 51 represents our 5th FDA clearance in 11 months and maintains our position at the forefront, introducing advanced, innovative, minimally disruptive spine surgery technologies. This addition to our product portfolio serves spine surgeons performing our screw-less minimally invasive procedure that prefer a slimmer profile and flared lower spikes. 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 proprietary ZIP ONE-STEP™ locking mechanism eliminates the use of a set screw. Each ZIP 51 implant features a large barrel designed for ZIP Graft™ or other bone material. The ZIP 51 is designed in various sizes to accommodate variations in patient anatomy.
In our drive to provide the best products possible for both surgeons and patients alike, all Aurora Spine products are pre-packaged sterile.
About Aurora Spine
Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies.
This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Information" in Aurora Spine's final prospectus (collectively, "forward-looking information"). Forward-looking information in this news release includes information concerning the proposed marketing and commercialization of Aurora Spine's products. Aurora Spine cautions investors of its securities about important factors that could cause Aurora Spine's actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.
Aurora Spine Corporation
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