Orthopaedic cement preparation/delivery kit

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

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Merit Medical Australia Pty Ltd
Class IIb
Authorization status:
Authorization number:

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Public Summary

Summary for ARTG Entry:


Merit Medical Australia Pty Ltd - Orthopaedic cement preparation/delivery kit

ARTG entry for

Medical Device Included Class IIb


Merit Medical Australia Pty Ltd

Postal Address

Unit 44 - 328 Reserve Road,Cheltenham, VIC, 3192


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.




Merit Medical Systems Inc

1600 West Merit Parkway

South Jordan, UTAH, 84095

United States Of America


1. Orthopaedic cement preparation/delivery kit

Product Type

Medical device system

Effective date



45253 Orthopaedic cement preparation/delivery kit

Intended purpose

The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of StabiliT ER2 Bone

Cement in vertebroplasty/kyphoplasty procedures in the treatment of pathological fractures of the

vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions

(hemangioma), and malignant lesions (metastatic cancers, myeloma).

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 12:41:56 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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