EBI AIS SPINE SYSTEM

K020887MQP5/16/2002

Applicant

EBI, L.P.

Intended Use

The EBI AIS Spine System is intended for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The EBI AIS Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI AIS Spine System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged time. The system must be used in conjunction with the EBI Omega 21 System or the EBI SpineLink System.

Indications for Use

The EBI AIS Spine System is intended for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The EBI AIS Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI AIS Spine System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged time. The system must be used in conjunction with the EBI Omega 21 System or the EBI SpineLink System.

Predicate Devices

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  • K990148, K001340 - Stackable Cage™™ System by Depuy Acromed (MQP)
  • K003275 - SynMesh™™ System by Synthes (MQP)
  • K010530 - Geo™ Structure by Interpore Cross (MQP)