Spinal cage

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

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Available from:
E4 Surgical Pty Ltd
Class IIb
Authorization status:
Authorization number:

Public Summary

Summary for ARTG Entry:


E4 Surgical Pty Ltd - Spinal cage

ARTG entry for

Medical Device Included Class IIb


E4 Surgical Pty Ltd

Postal Address

7 Bickleigh Street,Abbotsford, NSW, 2046


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.




Global Biomedica s r o

Ostravska 555/24

, Cesky Tesin, 737 01

Czech Republic


1. Spinal cage

Product Type

Single Device Product

Effective date



38161 Spinal cage

Intended purpose

Device indicated for lumbar interbody fusion for the following indications:

1. Degenerative and postoperative spinal involvement in term of rupture, ostechondrosis, degenerative

stenosis, pseudarthrosis.

2. Traumatic disc involvement - only in the absence of traumatic vertebras involvement and significant

ligament instability of posterior column.

Specific Conditions

© 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 08.11.2019 at 10:34:09 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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