Aurora Spine Receives FDA 510(k) Clearance for Titanium Plasma Spray Coated Spinal Fusion Implants

Aurora Spine announced it has received U.S. Food and Drug Administration 510(k) clearance for sterile-packed titanium plasma spray coated spinal fusion implants. 

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The device is coated with Aurora Spine’s titanium plasma spray — TiNano — which allows for bone in-growth due to its porous structure.

 

“This FDA clearance is a major achievement for Aurora Spine,” said Trent J. Northcutt, president and CEO of the company. “These intervertebral implants are developed to support the entire spine from cervical to lumbar and to accommodate the company’s ZIP Minimally Invasive Interspinous Fusion System portfolio as well as other fusion products on the market.”

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