Sacroiliac

Main information

  • Trade name:
  • Sacroiliac joint arthrodesis implant
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Sacroiliac joint arthrodesis implant
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216752
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216752

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Sacroiliac joint arthrodesis implant

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. Sacroiliac joint arthrodesis implant

Product Type

Medical device system

Effective date

31/10/2013

GMDN

58733 Sacroiliac joint arthrodesis implant

Intended purpose

A sacroiliac fusion implant for stabilisation of the sacroiliac joint. This implantation is performed through a

posterior approach. The device is indicated for painful sacroiliac joints in skeletally mature patients,

requiring surgical stabilisation by bone grafting and internal fixation.

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 05:02:23 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