Fixation device, internal, spine, construct

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Globus Medical Australia Pty Ltd

Class:

Class IIb

Manufactured by:

Globus Medical Inc 2560 General Armistead Avenue, Audubon, PA, 19403 United States Of America

Therapeutic area:

37272 - Fixation device, internal, spine, construct

Therapeutic indications:

Fixation Device, Internal, Spine Construct [37272] The Transition Stabilization System is intended to provide spinal alignment and dynamic stabilization in skeletally mature patients in up to five contiguous levels of the thoracic, lumbar and sacral spine. The system is intended to be used for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, degenerative spondylolisthesis with objective evidence of neurologic impairment, spondylosis, spinal stenosis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion.

Authorization status:

A

Authorization date:

2012-04-11