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April 26, 2011

SI-Bone Receives FDA Approval for Modified iFuse Implant System

SI-BONE has received US Food and Drug Administration (FDA) approval for a major modification to its existing iFuse Implant System product, which is used to treat conditions such as sacroiliac joint disruptions and degenerative sacroiliitis. SI-BONE received FDA clearance in November 200

By cms admin

SI-BONE has received US Food and Drug Administration (FDA) approval for a major modification to its existing iFuse Implant System product, which is used to treat conditions such as sacroiliac joint disruptions and degenerative sacroiliitis.

SI-BONE received FDA clearance in November 2008 and CE mark in 2010 to market its iFuse Implant System, which uses a minimal incision for delivery and implantation of small titanium implants.

The implants are coated with a porous plasma spray that acts as an interference surface, designed to help decrease implant motion.

SI-BONE CEO Jeff Dunn said that the approval provides the company an advantage in the appropriate diagnosis of low back complaints including the SI joint and a minimally invasive surgical device option for patients with sacroiliac joint problems.

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