Metal-polymer composite spinal fusion cage

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:
292835

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Public Summary

Summary for ARTG Entry:

292835

Orthotech Pty Ltd - Metal-polymer composite spinal fusion cage

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

HumanTech Germany GmbH

Gewerbestrasse 5

, Steinenbronn, 71144

Germany

Products

1. Metal-polymer composite spinal fusion cage

Product Type

Single Device Product

Effective date

15/08/2017

GMDN

61230 Metal-polymer composite spinal fusion cage

Intended purpose

Intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically

due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically

designed as a small, hollow and/or porous, threaded or fenestrated cage (of several geometric forms) and

is a composite of non-bioabsorbable synthetic polymer and metal, e.g. PEEK and titanium (Ti), that is

implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient

space for bone fusion to occur.

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 06:59:28 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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