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Amedica receives 510(k) clearance for fusion devices with silicon nitride

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The FDA has issued 510(k) clearance for Amedica Corporation to market a second-generation family of cervical and lumbar interbody fusion devices manufactured with the company’s propriety silicon nitride biomaterial.

According to a company press release, the product portfolio expansion offers design enhancements, including a threaded insertion feature, additional footprints and design elements to allow surgeons to perform minimally invasive and lumbar lateral interbody fusion (LLIF) approaches.

“The enhancements we have made to our interbody line of products including the LLIF devices speak to our long-term commitment to improve interbody fusion procedures by providing a premium product that enhances the surgeon experience while dramatically improving patient outcomes,” Eric K. Olson, president and chief executive officer of Amedica, stated in the release.