Fixation device, internal, wire

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

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Available from:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class:
Class IIa
Authorization status:
Included
Authorization number:
289488

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Public Summary

Summary for ARTG Entry:

289488

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Fixation device, internal, wire

ARTG entry for

Medical Device Included Class IIa

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

30/05/2017

Product category

Medical Device Class IIa

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

Paragon 28 Inc

4B Inverness Ct East Suite 280

Englewood, Colorado, 80112

United States Of America

Products

1. Fixation device, internal, wire

Product Type

Single Device Product

Effective date

30/05/2017

GMDN

35685 Fixation device, internal, wire

Intended purpose

A wire temporarily placed in the bone as an attachment for mating instruments to guide accessory implants

and instruments. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)]. This is a single-use

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 01.12.2017 at 11:55:56 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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