Orthosis

Main information

  • Trade name:
  • Orthosis, leg, ankle/foot, unit
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Orthosis, leg, ankle/foot, unit
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222809
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222809

Ossur Australia - OA & Injury Solutions Pty Ltd - Orthosis, leg, ankle/foot, unit

ARTG entry for

Medical Device Included Class 1

Sponsor

Ossur Australia - OA & Injury Solutions Pty Ltd

Postal Address

PO Box 142,CROYDON, VIC, 3136

Australia

ARTG Start Date

25/04/2014

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

Spinal Solutions Inc

1971 Old Covington Road NE STE 103

Conyers, GA, 30013

United States Of America

Products

1. Orthosis, leg, ankle/foot, unit

Product Type

Single Device Product

Effective date

25/04/2014

GMDN

36206 Orthosis, leg, ankle/foot, unit

Intended purpose

An orthosis that encompassess the ankle joint and the whole or part of the foot. This device is body worn.

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 09.11.2017 at 07:48:22 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