Fixation

Main information

  • Trade name:
  • Fixation device, internal, pin
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218533
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218533

Device Technologies Australia Pty Ltd - Fixation device, internal, pin

ARTG entry for

Medical Device Included Class IIa

Sponsor

Device Technologies Australia Pty Ltd

Postal Address

Locked Bag 521,FRENCHS FOREST, NSW, 2086

Australia

ARTG Start Date

13/12/2013

Product category

Medical Device Class IIa

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

SI-Bone Inc

3055 Olin Avenue Suite 2200

San Jose, CA, 95128

United States Of America

Products

1. Fixation device, internal, pin

Product Type

Single Device Product

Effective date

13/12/2013

GMDN

32854 Orthopaedic bone pin, non-bioabsorbable

Intended purpose

The Steinmann pin is a firm metal pin that is sharpened on one end. The implant system incorporates the

Steinmann Pin as a component to facilitate implantation of the Implant. It is used as a guide in this product

configuration. Steinmann pins are commonly used in orthopedic surgery for securing the ends of fractured

bones to transfix bone for traction or fusion.

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 02.12.2017 at 04:45:29 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