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:
  • 219165
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219165

Tornier Pty Ltd - Orthopaedic implantation application software

ARTG entry for

Medical Device Included Class Im

Sponsor

Tornier Pty Ltd

Postal Address

PO Box 230,BELROSE, NSW, 2085

Australia

ARTG Start Date

13/01/2014

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

IMASCAP

65 Place Copernic

, Plouzane, 29280

France

Products

1. Orthopaedic implantation application software

Product Type

Single Device Product

Effective date

13/01/2014

GMDN

46470 Orthopaedic implantation application software

Intended purpose

Software used pre-operatively as a planning tool to determine the size and positioning of prosthetic

components in relation to anatomical landmarks based on CT images of the patient. Patient-specific

(custom) guides based on the preoperative planning may be subsequently generated.

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 08:17:48 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