Laminoplasty

Main information

  • Trade name:
  • Laminoplasty Fixation System - Spinal fixation plate, non-biodegradable
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Laminoplasty Fixation System - Spinal fixation plate, non-biodegradable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219536
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219536

Globus Medical Australia Pty Ltd - Laminoplasty Fixation System - Spinal fixation plate, non-biodegradable

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

24/01/2014

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. Laminoplasty Fixation System - Spinal fixation plate, non-biodegradable

Product Type

Medical device system

Effective date

24/01/2014

GMDN

46653 Spinal fixation plate, non-biodegradable

Intended purpose

For use in the cervical and thoracic spine in laminoplasty procedures. Used to hold bone allograft material

in place in order to prevent the allograft from expulsion or impinging the spinal cord.

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 07:15:18 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.

Visit www.tga.gov.au for contact information