Fixation device, internal, spine, construct

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:

BEACON? Stabilization System,when used as posterior pedicle screw systems,is intended to provide immobilization & stabilization of spinal segments in skeletally mature patients as adjunct to fusion in treatment of following acute & chronic instabilities or deformities of thoracic,lumbar & sacral spine:degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history & radiographic studies),degenerative spondylolisthesis with objective evidence of neurologic impairment,fracture,dislocation,scoliosis,kyphosis,spinal tumor,pseudoarthrosis & failed previous fusion.In addition,it is intended for treatment of severe spondylolisthesis (Grades 3 & 4) of L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft,having implants attached to lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion.Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.When used as a posterior non-pedicle screw fixation system (using REVERE? hooks),it is intended for treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history & radiographic studies),spinal stenosis,spondylolisthesis,spinal deformities (i.e. scoliosis,kyphosis,and/or lordosis,Scheuermann?s disease),fracture,pseudarthrosis,tumor resection,and/or failed previous fusion.Overall levels of fixation are T1-sacrum/ilium.When used as an anterolateral thoracolumbar system,it is intended for anterolateral screw (with or without staple) fixation for following indications:degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies),spinal stenosis,spondylolisthesis,spinal deformities (i.e. scoliosis,kyphosis,and/or lordosis),fracture or dislocation of the thoracolumbar spine,pseudoarthrosis,tumor resection,and/or failed previous fusion.Levels of screw fixation are T8-L5.

Authorization status:

A

Authorization date:

2014-01-13