Fixation

Main information

  • Trade name:
  • Fixation device, internal, spine, construct
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Fixation device, internal, spine, construct
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219169
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219169

Globus Medical Australia Pty Ltd - Fixation device, internal, spine, construct

ARTG entry for

Medical Device Included Class IIb

Sponsor

Globus Medical Australia Pty Ltd

Postal Address

PO Box 8151,Baulkham Hills Business Centre, NSW, 2153

Australia

ARTG Start Date

13/01/2014

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Globus Medical Inc

2560 General Armistead Avenue

Audubon, PA, 19403

United States Of America

Products

1. Fixation device, internal, spine, construct

Product Type

Medical device system

Effective date

13/01/2014

GMDN

37272 Fixation device, internal, spine, construct

Intended purpose

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.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 08:16:46 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

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