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The Xenco Medical Posterior Cervical System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Xenco Medical Posterior Cervical System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

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I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the "Xenco Medical Posterior Cervical System," which primarily focuses on regulatory approval and indications for use. It does not contain details about specific acceptance criteria for device performance or any studies conducted to demonstrate that the device meets such criteria.

The information I can provide from the document includes:

• Device Name: Xenco Medical Posterior Cervical System
• Regulatory Class: Unclassified
• Product Code: NKG, KWP
• Indications for Use: To provide immobilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the cervical spine (C1 to C7) and thoracic spine (T1-T3), including traumatic fractures/dislocations, instability/deformity, failed previous fusions, tumors, and degenerative disease. Also, to restore spinal column integrity for a limited time in patients with advanced stage tumors where life expectancy is short.

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