Main information

  • Trade name:
  • Orthopaedic implant inserter/extractor
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Orthopaedic implant inserter/extractor
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222784
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Zimmer Pty Ltd - Orthopaedic implant inserter/extractor

ARTG entry for

Medical Device Included Class 1


Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




Biomet Trauma

56 East Bell Drive

Warsaw, IN, 46581

United States Of America


1. Orthopaedic implant inserter/extractor

Product Type

Single Device Product

Effective date



12696 Orthopaedic implant inserter/extractor

Intended purpose

A hand-held manual surgical instrument designed to insert or extract an orthopaedic device (e.g., an

orthopaedic bone nail, or a bone fixation plate) into or out of the body. It is typically made of stainless

steel/synthetic material and the surgeon can make strikes on the proximal end with a surgical hammer or

mallet to insert/extract the device. This is a reusable device.

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 09.11.2017 at 07:51:02 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