- Aurora Spine (ASG) has received FDA 510(k) clearance for its DEXA SOLO-L spinal fusion system
- The DEXA SOLO-L, part of the DEXA Technology Platform, is a standalone device for anterior and lateral lumbar interbody fusion (ALIF & LLIF) procedures
- It is the first of its kind device for lumbar spine in the world
- Aurora Spine focuses on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies
- Aurora Spine Corp. (ASG) was down 7.41 per cent, trading at C$0.375 per share as of 4:20 pm ET
Aurora Spine (ASG) has received FDA 510(k) clearance for its DEXA SOLO-L spinal fusion system.
The 3D printed standalone anterior lumbar interbody fusion device (ALIF) was developed as part of the world’s first bone density matched implant based on Aurora’s patented DEXA Technology Platform.
The DEXA SOLO-L, part of the DEXA Technology Platform, is a standalone device for anterior and lateral lumbar interbody fusion (ALIF & LLIF) procedures. It is the first of its kind device for lumbar spine in the world.
The device is also the first color-coded, bone-mimicking structure implant in the marketplace. It will help doctors match the implant to the patients bone quality and density to a personalized implant.
The DEXA-L product line follows the recently released DEXA-C cervical implant product line.
Trent Northcutt, the President and Chief Executive Officer of Aurora Spine commented on the news.
“We are thrilled to receive this new approval for our DEXA SOLO-L device, the world’s first patented and FDA-cleared, color-coded ALIF standalone device. This clearance is an important step to gain new surgeon customers and new sales distribution opportunities nationwide to drive more revenue.”
Aurora Spine focuses on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies. The company’s product portfolio includes implants, surgical tools, biologics, and Non-Fusion.
Aurora Spine Corp. (ASG) was down 7.41 per cent, trading at C$0.375 per share as of 4:20 pm ET.
