Bone-screw internal spinal fixation system, sterile

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

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Available from:
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Class:
Class IIb
Authorization status:
Included
Authorization number:
293276

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Public Summary

Summary for ARTG Entry:

293276

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes - Bone-screw internal spinal fixation system, 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

28/08/2017

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

Synthes GmbH

3 Eimattstrasse

Oberdorf, , 4436

Switzerland

Products

1. Bone-screw internal spinal fixation system, sterile

Product Type

Single Device Product

Effective date

28/08/2017

GMDN

61324 Bone-screw internal spinal fixation system, sterile

Intended purpose

A sterile fixation system, comprising of screws, rods, hooks and connectors, designed to provide precise

and segmental stabilisation of the spine and indicated for the treatment of spinal instabilities, deformities,

and trauma.

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 11:17:04 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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