Fixation plate, growth-correction

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

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Available from:
Zimmer Biomet Pty Ltd
Class:
Class 1
Authorization status:
Included (Export Only)
Authorization number:
289724

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Public Summary

Summary for ARTG Entry:

289724

Zimmer Biomet Pty Ltd - Fixation plate, growth-correction

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

5/06/2017

Product category

Medical Device Class 1

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

Biomet Trauma

56 East Bell Drive

Warsaw, IN, 46581

United States Of America

Products

1. Fixation plate, growth-correction

Product Type

Single Device Product

Effective date

5/06/2017

GMDN

44896 Fixation plate, growth-correction

Intended purpose

An implanted device used to redirect the angle of growth of long bones in paediatric patients where the

growth plates (epiphysial cartilage) are not fused, to allow for the gradual correction of congenital or

acquired deformities (e.g., valgus, varus, or flexion deformities of the knee, ankle, or elbow).

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 06:04:46 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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