Prosthesis, internal, spine, vertebral body

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Life Healthcare Pty Ltd

Class:

Class IIb

Manufactured by:

X-Spine Systems Inc 452 Alexandersville Road, Miamisburg, OH, 45342 United States Of America

Therapeutic area:

34170 - Prosthesis, internal, spine, vertebral body

Therapeutic indications:

When used as a vertebral body replacement, the X-Spine Calix System is intended for use in the thoracic and/or thoracolumbar spine to replace a collapsed, damaged or unstable vertebral body resected or excised due to tumour or trauma. The Calix device, when used as a vertebral body replacement, can be packed with either allograft or autograft. When used as an intervertebral body fusion device, the X-Spine Calix System is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.

Authorization status:

A

Authorization date:

2010-03-30