EBI ESL SPINE SPACER SYSTEM

K040482MQP4/16/2004

Applicant

EBI, L.P.

Intended Use

The EBI ESL Spine Spacer 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 ESL Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI ESL 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 time. The system must be used in conjunction with the EBI NGC Spinal System, EBI Omega 21 Spinal System or the EBI SpineLink II Spinal System.

Indications for Use

The EBI ESL Spine Spacer 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 ESL Spine Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The EBI ESL 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 time. The system must be used in conjunction with the EBI NGC Spinal System, EBI Omega 21 Spinal System or the EBI SpineLink II Spinal System.

Predicate Devices

  • K020887 - EBI Ionic Spine Spacer System (MQP)
  • K024364 - Synthes Vertebral Spacer Ti (MQP)