Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Orthotech Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
292837

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Public Summary

Summary for ARTG Entry:

292837

Orthotech Pty Ltd - Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

ARTG entry for

Medical Device Included Class IIb

Sponsor

Orthotech Pty Ltd

Postal Address

PO Box 203,ALBION, QLD, 4010

Australia

ARTG Start Date

15/08/2017

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

Orthofix SRL

Via Delle Nazioni 9

BUSSOLENGO VERONA, , 37012

Italy

Products

1. Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Product Type

Medical device system

Effective date

15/08/2017

GMDN

61688 Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

Intended purpose

A sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of

the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for

limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of

materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade

metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of

the implants such as screwdrivers or drills.

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 03.11.2017 at 06:58:45 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

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