Eminent Spine’s SI Screw System Received FDA 510(k) Clearance on June 4, 2024

 Eminent Spine received 510(k) approval on the 3D Printed Titanium and Machined Titanium SI Screw System as of June 4, 2024. Eminent Spine will showcase the SI Screw System at the State of Spine Surgery Think Tank annual conference in Cabo, MX from June 20-22, 2024, as well as the ASPN Annual Conference in Miami, FL, from July 11-14, 2024.

Eminent Spine’s SI Screw System is comprised of various sizes and configurations to accommodate individual patient anatomy. The System was designed with the following: tapered nose that allows for ease of insertion, sharp tip that easily penetrates bone, lengths that range from 20mm – 90mm, diameters of 8.5mm, 10mm, 11.5mm, and 13.0mm, head and headless screw options, fenestrated and self-harvesting threads, and two different materials (3D Printed Titanium and Machined Titanium). The Eminent Spine SI Screw System was approved for lateral, superior lateral, and S2-AI approaches. The implants are offered non-sterile.