Sam Brusco, Associate Editor06.06.22
Aurora Spine has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its DEXA SOLO-L spinal fusion system. The 3D-printed standalone anterior lumbar interbody fusion (ALIF) device is part of a bone density matched implant based on the company’s technology platform.
DEXA SOLO-L, according to the company, is the first device of its kind for lumbar spine as a color-coded, bone-mimicking structure implant. This line follows this company’s recently released DEXA-C cervical implant line.
"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,” Aurora Spine CEO Trent Northcutt told the press. “This clearance is an important step to gain new surgeon customers and new sales distribution opportunities nationwide to drive more revenue."
Laszlo Garamszegi, chief technology officer of Aurora Spine, added, "This FDA clearance is another significant achievement for our R&D team. The DEXA SOLO-L approval demonstrates our unwavering commitment to game-changing innovation around our entire bone mimicking DEXA Technology Platform. We will continue developing proprietary products to strengthen our product offerings, and build off our patent portfolio, especially our patented DEXA Technology Platform.”
DEXA SOLO-L, according to the company, is the first device of its kind for lumbar spine as a color-coded, bone-mimicking structure implant. This line follows this company’s recently released DEXA-C cervical implant line.
"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,” Aurora Spine CEO Trent Northcutt told the press. “This clearance is an important step to gain new surgeon customers and new sales distribution opportunities nationwide to drive more revenue."
Laszlo Garamszegi, chief technology officer of Aurora Spine, added, "This FDA clearance is another significant achievement for our R&D team. The DEXA SOLO-L approval demonstrates our unwavering commitment to game-changing innovation around our entire bone mimicking DEXA Technology Platform. We will continue developing proprietary products to strengthen our product offerings, and build off our patent portfolio, especially our patented DEXA Technology Platform.”