Orthosis

Main information

  • Trade name:
  • Orthosis, arm, finger
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Orthosis, arm, finger
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222584
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222584

LMT Surgical Pty Ltd - Orthosis, arm, finger

ARTG entry for

Medical Device Included Class Is

Sponsor

LMT Surgical Pty Ltd

Postal Address

PO Box 41,PADDINGTON, QLD, 4064

Australia

ARTG Start Date

16/04/2014

Product category

Medical Device Class Is

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

Citieffe SRL

Via Armaroli 21-14

Calderara di Reno, Bologna, 40012

Italy

Products

1. Orthosis, arm, finger

Product Type

Single Device Product

Effective date

16/04/2014

GMDN

41456 Orthosis, arm, finger

Intended purpose

The MiniFlo Fixator Extension devices are intended for use as part of an external orthosis (fixator) system.

The fixator is a framework intended to maintain the position of implanted bone screws (supplied

separately) to stabilize finger bones to promote treatment and healing. The extension devices allow

extension in the length of the fixator.

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 08:59:26 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