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:

The REVOLVE? Stabilization System, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis and failed previous fusion. In addition, the REVOLVE? Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixat

Authorization status:

A

Authorization date:

2011-09-29