NuVasive (San Diego) recently announced that it was the first company to receive FDA clearance for a unique neck implant known as a cervical corpectomy cage—a device used to replace a cervical vertebrae and adjacent discs in the treatment of multilevel cervical spondylototic myelopathy (CSM), the most common spinal disorder in the world. NuVasive’s announcement describes the product as a "first-ever FDA 510(k) clearance” for this product type.
NuVasive was able to convince FDA in less than one month that the novel product X-Core Mini Cervical Expandable VBR system (K151651) was substantially equivalent to two predicate devices: the NuVasive X-Core Expandable VBR System (K142205) and the NuVasive CoRoent system (K081611).
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NuVasive was able to convince FDA in less than one month that the novel product X-Core Mini Cervical Expandable VBR system (K151651) was substantially equivalent to two predicate devices: the NuVasive X-Core Expandable VBR System (K142205) and the NuVasive CoRoent system (K081611).
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