PARAMOUNT VBR SYSTEM

K062759MQP1/12/2007

Applicant

INNOVATIVE SPINAL TECHNOLOGIES INC

Intended Use

The Paramount™™ VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Paramount™™ VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the Paramount™™ Pedicle Screw System.

Indications for Use

The Paramount™™ VBR is indicated for use for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma / fracture to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Paramount™™ VBR may be used singly or in pairs in the thoracolumbar spine (T1 to L5) with or without supplemental fixation, such as the Paramount™™ Pedicle Screw System.

Predicate Devices

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  • K043206 - Pioneer® Vertebral Spacer (MQP)
  • K042930 - SpineVision Spacevision™™ Cage (MQP)