Internal

Main information

  • Trade name:
  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 295343
  • Last update:
  • 01-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

295343

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Internal orthopaedic fixation system, plate/screw,

non-bioabsorbable, sterile

ARTG entry for

Medical Device Included Class IIb

Sponsor

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Postal Address

PO Box 134,NORTH RYDE, NSW, 2113

Australia

ARTG Start Date

20/10/2017

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

Synthes GmbH

3 Eimattstrasse

Oberdorf, , 4436

Switzerland

Products

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

Product Type

Single Device Product

Effective date

20/10/2017

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. It

typically consists of a set of bone fixation plates, screws, wires, and pins. It may also include instruments

for the attachment of the implants.

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 01.12.2017 at 11:07:32 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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