Orthopaedic

Main information

  • Trade name:
  • Orthopaedic implantation application software
  • Class:
  • Class Im
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Orthopaedic implantation application software
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217041
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217041

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Orthopaedic implantation application software

ARTG entry for

Medical Device Included Class Im

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

8/11/2013

Product category

Medical Device Class Im

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

Materialise NV

Technologielaan 15

Leuven, , 3001

Belgium

Products

1. Orthopaedic implantation application software

Product Type

Single Device Product

Effective date

8/11/2013

GMDN

46470 Orthopaedic implantation application software

Intended purpose

Intended for use as a software interface and image segmentation system for the transfer of imaging

information from a medical scanner such as a CT scanner or a Magnetic Resonance Imaging scanner.

The device is also used as pre-operative software for simulating /evaluating implant placement and

surgical treatment options.

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 04:59:56 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