Eminent Spine’s additively manufactured SI Screw System receives FDA 510(k) clearance
June 13, 2024
Eminent Spine, Plano, Texas, USA, has received 510(k) approval for its additively manufactured titanium and machined titanium SI Screw System. The company announced it will showcase the SI Screw System range at the State of Spine Surgery Think Tank annual conference in Cabo, Mexico from June 20-22, 2024, as well as the ASPN Annual Conference in Miami, Florida, 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 a tapered nose that allows for ease of insertion and a sharp tip that easily penetrates bone. Lengths range from 20 – 90 mm, with diameters of 8.5 mm, 10 mm, 11.5 mm, and 13.0 mm. There are head and headless screw options, fenestrated and self-harvesting threads.
The Eminent Spine SI Screw System was approved for lateral, superior lateral, and S2-AI approaches.
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