Fixation

Main information

  • Trade name:
  • Fixation system, internal, spinal, bone screw
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Fixation system, internal, spinal, bone screw
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216751
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216751

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Fixation system, internal, spinal, bone screw

ARTG entry for

Medical Device Included Class IIb

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

31/10/2013

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

Signus Medizintechnik GmbH

Industriestrasse 2

Alzenau, , D-63755

Germany

Products

1. Fixation system, internal, spinal, bone screw

Product Type

Medical device system

Effective date

31/10/2013

GMDN

43257 Fixation system, internal, spinal, bone screw

Intended purpose

The pedicle screw and fixation rod system is indicated for stabilisation of the spine until stability has been

achieved in patients who have undergone surgical fusion of the spine. Indications for all pedicle screw

systems: Instability of the spine or deviations from the normal position of the spine, Fractures,

Postoperative or degenerative instability, Tumours and spondylodiscitis, Correction of Meyerding grade 1

spondylolisthesis, Disc prolapse, Stenoses of the lumbar spine, Disc resection, Abnormal

lordosis/kyphosis/scoliosis and Degenerative segmental disease. The system is furthermore indicated in

situations where external immobilisation by means of a plaster cast or splint is not possible.

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 02.12.2017 at 05:02:39 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