Summary for ARTG Entry:
Globus Medical Australia Pty Ltd - Fixation device, internal, spine, construct
ARTG entry for
Medical Device Included Class IIb
Globus Medical Australia Pty Ltd
PO Box 8151,Baulkham Hills Business Centre, NSW, 2153
ARTG Start Date
Medical Device Class IIb
- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,
Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations
2002 for relevant information.
- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal
offence; and civil penalties may apply.
Globus Medical Inc
2560 General Armistead Avenue
Audubon, PA, 19403
United States Of America
1. Fixation device, internal, spine, construct
Medical device system
37272 Fixation device, internal, spine, construct
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.
No Specific Conditions included on Record
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