EBI CAS SPINE SPACER SYSTEM

K042268MQP10/27/2004

Applicant

EBI, L.P.

Intended Use

The EBI CAS Spine Spacer System is intended for use in the thoracolumbar spine (i.e., T1-L5) for partial replacement (i.e., partial vertebrectomy) of 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 CAS Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI CAS Spine Spacer 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 period of time. The system must be used in conjunction with the EBI NGC Spinal System, EBI Omega 21 Spinal System, EBI SpineLink II Spinal System, or the EBI Array Spinal System.

Indications for Use

The EBI CAS Spine Spacer System is intended for use in the thoracolumbar spine (i.e., T1-L5) for partial replacement (i.e., partial vertebrectomy) of 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 CAS Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI CAS Spine Spacer 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 period of time. The system must be used in conjunction with the EBI NGC Spinal System, EBI Omega 21 Spinal System, EBI SpineLink II Spinal System, or the EBI Array Spinal System.

Predicate Devices

  • K040482 - EBI ESL Spine Spacer System (MQP)
  • K020887 - EBI Ionic Spine Spacer System ()