Aurora Spine has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for its 3D-printed DEXA SOLO-L anterior lumbar interbody fusion (ALIF) device.
The DEXA SOLO-L, part of the DEXA technology platform, is a standalone device for ALIF and lateral lumbar interbody fusion (LLIF) procedures and is, according to Aurora Spine, the first of its kind device for lumbar spine in the world. It is, adds the firm, also the first colour-coded, bone-mimicking structure implant in the marketplace and will help doctors match the implant to the patents bone quality and density.
The DEXA-L product line follows the recently released DEXA-C cervical implant product line.
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, colour-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.”
Laszlo Garamszegi, chief technology officer of Aurora Spine, added: “This FDA clearance is another significant achievement for our research and development team. The DEXA SOLO-L approval demonstrates our unwavering commitment to game-changing innovation around our entire bone mimicking DEXA Technology Platform.”