Orthopaedic fixation plate, non-bioabsorbable, non-sterile

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

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Available from:
Stryker Australia Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
291616

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Public Summary

Summary for ARTG Entry:

291616

Tornier Pty Ltd - Orthopaedic fixation plate, non-bioabsorbable, non-sterile

ARTG entry for

Medical Device Included Class IIb

Sponsor

Tornier Pty Ltd

Postal Address

PO Box 230,BELROSE, NSW, 2085

Australia

ARTG Start Date

17/07/2017

Product category

Medical Device Class IIb

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

Tornier SAS

161 Lavoisier

, Montbonnot St Martin, 38330

France

Products

1. Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Product Type

Single Device Product

Effective date

17/07/2017

GMDN

61573 Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Intended purpose

A collection of non-biodegradable plates and screws of various sizes that are implanted onto fractured

bone fragments to bridge and stabilise the fracture gap. This device is intended to be sterilised prior to

use.

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 03.11.2017 at 11:59:26 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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