Polymeric spinal fusion cage, sterile

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

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Available from:
Kynesis Pty Ltd
Class IIb
Authorization status:
Authorization number:

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Public Summary

Summary for ARTG Entry:


Kynesis Pty Ltd - Polymeric spinal fusion cage, sterile

ARTG entry for

Medical Device Included Class IIb


Kynesis Pty Ltd

Postal Address

PO Box 326,KENTHURST, NSW, 2156


ARTG Start Date


Product category

Medical Device Class IIb



Approval area

Medical Devices


- 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.




A-Spine Asia Co Ltd

11F No 1 Alley 30 Lane 358 Ruiguang Road

Neihu District, Tapei,

Taiwan (Province of China)


1. Polymeric spinal fusion cage, sterile

Product Type

Single Device Product

Effective date



60847 Polymeric spinal fusion cage, sterile

Intended purpose

The device is intended to be used with autogenous bone graft for spinal interbody fusion surgery. The

device is manufactured from PEEK.

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

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Produced at 03.11.2017 at 04:37:45 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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