Aurora Spine Gains FDA 510(k) Clearance for DEXA SOLO-L

By Julie A. Vetalice

Aurora Spine Gains FDA 510(k) Clearance for DEXA SOLO-L

Aurora Spine received FDA 510(k) clearance to market its DEXA SOLO-L™ spinal fusion system. The 3D-printed standalone device was developed as part of what the company claims is the world’s first bone density-matched implant based on Aurora’s DEXA Technology Platform.

DEXA SOLO-L is intended for use in anterior and lateral lumbar interbody fusion (ALIF & LLIF) procedures and is reportedly the first of its kind device for lumbar spine. It is also the first color-coded, bone-mimicking™ structure implant in the marketplace and is designed to help doctors match the implant to the patents bone quality and density.

Aurora’s DEXA implants match a patient’s bone density and quality to a personalized implant. The DEXA-L product line follows the recently released DEXA-C cervical implant product line.

Mr. Trent Northcutt, President and Chief Executive Officer of Aurora Spine, said, "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."

Source: Aurora Spine

Product Labels: Lumbar Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory