The DEXA SOLO-L anterior lumbar interbody fusion (ALIF) device manufactured by Aurora Spine has received 510K clearance from the US Food and Drug Administration (FDA).
The 3D printed standalone device for anterior and lateral lumbar interbody fusion (ALIF LLIF) procedures is based on the company's DEXA Technology Platform.
The DEXA SOLO-L Spinal Fusion devices Market is said to be the first of its kind for the lumbar spine and was developed as a bone density-matched implant.
Additionally, it is the first color-coded ALIF standalone device available, allowing doctors to match an implant to a patient's bone quality and density.
Trent Northcutt, president and CEO of Aurora Spine, stated: We are overjoyed to have our DEXA SOLO-L device, the first color-coded ALIF standalone device that has been patented and cleared by the FDA, given this new approval.
"This clearance is a crucial step in expanding sales distribution opportunities nationwide and acquiring new surgeon customers to increase revenue."
The company asserts that its DEXA implants are the first in the world to match the quality and bone density of a patient in order to provide a individualized implant.
Following the recent release of the DEXA-C cervical implant product line, the DEXA-L product line is now available for purchase.
Laszlo Garamszegi, chief technology officer for Aurora Spine, stated: The approval of DEXA SOLO-L demonstrates our unwavering dedication to game-changing innovation in the DEXA Technology Platform's entirety.
"We will continue developing proprietary products to strengthen our product offerings and build on our patent portfolio, particularly our patented DEXA Technology Platform," reads the statement.