MUTARS

Main information

  • Trade name:
  • MUTARS Total Elbow Replacement - Hinged total elbow prosthesis
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • MUTARS Total Elbow Replacement - Hinged total elbow prosthesis
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221739
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221739

Oceania Orthopaedics Pty Ltd - MUTARS Total Elbow Replacement - Hinged total elbow prosthesis

ARTG entry for

Medical Device Included Class IIb

Sponsor

Oceania Orthopaedics Pty Ltd

Postal Address

PO Box 89,ALBION, QLD, 4010

Australia

ARTG Start Date

27/03/2014

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

Implantcast GmbH

Luneburger Schanze 26

, Buxtehude, D 21614

Germany

Products

1. MUTARS Total Elbow Replacement - Hinged total elbow prosthesis

Product Type

Medical device system

Effective date

27/03/2014

GMDN

40124 Hinged total elbow prosthesis

Intended purpose

Intended to be implanted to replace the articulating surfaces of a damaged and/or degenerative elbow

joint.

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 10.11.2017 at 12:00:01 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