MiniFlo

Main information

  • Trade name:
  • MiniFlo External Fixator System - Orthosis, arm, finger
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • MiniFlo External Fixator System - Orthosis, arm, finger
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222613
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222613

LMT Surgical Pty Ltd - MiniFlo External Fixator System - Orthosis, arm, finger

ARTG entry for

Medical Device Included Class IIa

Sponsor

LMT Surgical Pty Ltd

Postal Address

PO Box 41,PADDINGTON, QLD, 4064

Australia

ARTG Start Date

17/04/2014

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

Citieffe SRL

Via Armaroli 21-14

Calderara di Reno, Bologna, 40012

Italy

Products

1. MiniFlo External Fixator System - Orthosis, arm, finger

Product Type

Medical device system

Effective date

17/04/2014

GMDN

41456 Orthosis, arm, finger

Intended purpose

The MiniFlo Fixator is a system comprising a sterile external orthosis (external synthesis device), sterile

instruments, and sterile K-wire. The orthosis (fixator) is an externally applied framework intended to

maintain the position of implanted bone screws (supplied separately) to allow stabilization of finger bones

to promote treatment and healing. The K-wire (Class IIa) is transiently implanted during the surgical

procedure when applying 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 08:52:00 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