Patient rehabilitation interactive software

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

Buy It Now

Available from:
Zimmer Biomet Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
323752

Public Summary

Summary for ARTG Entry:

323752

Zimmer Biomet Pty Ltd - Patient rehabilitation interactive software

ARTG entry for

Medical Device Included Class 1

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

18/09/2019

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

Zimmer US Inc

601 Fifth Street NW

Grand Rapids, Michigan, 49504

United States Of America

Products

1. Patient rehabilitation interactive software

Product Type

Single Device Product

Effective date

18/09/2019

GMDN

47518 Patient rehabilitation interactive software

Intended purpose

The Zimmer Biomet application provides a mobile electronic communication platform designed to enhance

the engagement between healthcare providers and their patients and to encourage patients to complete

tasks as a part of their provider's care plan for preoperative and postoperative joint replacement

procedures involving Zimmer Biomet prosthesis.

Specific Conditions

© 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 08.11.2019 at 10:22:50 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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