Robot

Main information

  • Trade name:
  • Robot, surgical, operation unit
  • Class:
  • Class Im
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Robot, surgical, operation unit
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216979
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216979

Zimmer Biomet Pty Ltd - Robot, surgical, operation unit

ARTG entry for

Medical Device Included Class Im

Sponsor

Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

6/11/2013

Product category

Medical Device Class Im

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

Orthalign Inc

120 Columbia Suite 500

Aliso Viejo, CA, 92656

United States Of America

Products

1. Robot, surgical, operation unit

Product Type

Medical device system

Effective date

6/11/2013

GMDN

38678 Robotic surgical system

Intended purpose

The KneeAlign system is a computer assisted surgery device designed to assist the surgeon in the

alignment of the tibial and femoral cutting guides during total knee arthroplasty. The system consists of the

sterile, single use palm sized navigation unit and associated reusable instrumentation

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 03:43:07 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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Europe - EFSA - European Food Safety Authority Publications

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