Summary for ARTG Entry:
Zimmer Pty Ltd - Orthopaedic implant inserter/extractor
ARTG entry for
Medical Device Included Class 1
Zimmer Biomet Pty Ltd
Locked Bag 1310,FRENCHS FOREST, NSW, 2086
ARTG Start Date
Medical Device Class 1
- 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.
56 East Bell Drive
Warsaw, IN, 46581
United States Of America
1. Orthopaedic implant inserter/extractor
Single Device Product
12696 Orthopaedic implant inserter/extractor
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.
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.
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