Ultra-Drive - Extractor, cement, orthopaedic

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

Buy It Now

Available from:
Zimmer Biomet Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
322322

Public Summary

Summary for ARTG Entry:

322322

Zimmer Biomet Pty Ltd - Ultra-Drive - Extractor, cement, orthopaedic

ARTG entry for

Medical Device Included Class IIa

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

27/08/2019

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

Biomet Orthopedics also T/A Biomet Sports

Medicine /Biomet Biologics /Biomet Trauma

56 East Bell Drive PO Box 587

Warsaw, Indiana, 56581

United States Of America

Products

1. Ultra-Drive - Extractor, cement, orthopaedic

Product Type

Medical device system

Effective date

27/08/2019

GMDN

37065 Extractor, cement, orthopaedic

Intended purpose

The Ultradrive 3 is indicated for cutting and removal of bone and acrylic bone cement in orthopedic

applications. The Ultra-Drive 3 consists of a control console, a footswitch, a

handpiece with associated cables. The system is intended to be used with disposable accessories.

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 02.11.2019 at 05:54:57 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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