Orthopaedic bone screw, non-bioabsorbable, sterile

Australia - English - Department of Health (Therapeutic Goods Administration)

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Tornier Pty Ltd
Class IIb
Authorization number:

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Public Summary

Summary for ARTG Entry:


Tornier Pty Ltd - Orthopaedic bone screw, non-bioabsorbable, sterile

ARTG entry for

Medical Device Included Class IIb


Tornier Pty Ltd

Postal Address

PO Box 230,BELROSE, NSW, 2085


ARTG Start Date


Product category

Medical Device Class IIb



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.




Tornier SAS

161 Lavoisier

, Montbonnot St Martin, 38330



1. Orthopaedic bone screw, non-bioabsorbable, sterile

Product Type

Single Device Product

Effective date



46646 Orthopaedic bone screw, non-bioabsorbable, sterile

Intended purpose

A device for internal fracture fixation that holds plates or nails to the bone, fastens soft tissue to bone or

provides interfragmentary stabilisation for bone. This device is also used in orthopaedic surgery.

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

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Produced at 03.11.2017 at 11:36:21 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

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