Fixation

Main information

  • Trade name:
  • Fixation device, internal, staple
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Fixation device, internal, staple
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221403
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221403

Orthotech Pty Ltd - Fixation device, internal, staple

ARTG entry for

Medical Device Included Class IIb

Sponsor

Orthotech Pty Ltd

Postal Address

PO Box 203,ALBION, QLD, 4010

Australia

ARTG Start Date

18/03/2014

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

Neosteo

Malleve 2A 1 boulevard Jean Moulin

, Nantes, F-44100

France

Products

1. Fixation device, internal, staple

Product Type

Single Device Product

Effective date

18/03/2014

GMDN

16103 Fixation device, internal, staple

Intended purpose

The staple allows the fixation of the two bone fragments. Both legs are inserted into the cortical bone and

are linked by a central bridge, providing mechanical stability for the bone whilst it is consolidating.

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 01:11:12 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