Leg internal-external

Main information

  • Trade name:
  • Leg internal-external prosthesis intrafemoral bar
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Leg internal-external prosthesis intrafemoral bar
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220667
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220667

Surgien Pty Ltd - Leg internal-external prosthesis intrafemoral bar

ARTG entry for

Medical Device Included Class 1

Sponsor

Surgien Pty Ltd

Postal Address

PO Box 7430,ST KILDA ROAD, VIC, 8004

Australia

ARTG Start Date

3/03/2014

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

Integrum AB

Krokslatts Fabriker 50 Molndal

, , 431 37

Sweden

Products

1. Leg internal-external prosthesis intrafemoral bar

Product Type

Single Device Product

Effective date

3/03/2014

GMDN

58743 Leg internal-external prosthesis intrafemoral bar

Intended purpose

OPRA Connector Medical device intended to connect the Osseointegration OPRA System to external

prosthetic components.It is designed to protect the OPRA System from high mechanical forces whilst

weight loading and training.

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 03:28:35 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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