Surgical screwdriver, single-use, sterile

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

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Avania Pty Ltd
Class IIa
Authorization status:
Authorization number:

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Public Summary

Summary for ARTG Entry:


Five Corners Pty Ltd - Surgical screwdriver, single-use, sterile

ARTG entry for

Medical Device Included Class IIa


Five Corners Pty Ltd

Postal Address

13/76 Reserve Road,ARTARMON, NSW, 2064


ARTG Start Date


Product category

Medical Device Class IIa



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.




Providence Medical Technology Inc

1331 N California Blvd Suite 320

Walnut Creek, CA, 94596

United States Of America


1. Surgical screwdriver, single-use, sterile

Product Type

Single Device Product

Effective date



58776 Surgical screwdriver, single-use, sterile

Intended purpose

The DTRAX Bone Screw Delivery is a posterior fixation delivery instrument that enables distraction of the

facet joint, decompression of the nerve root and spinal stabilization.

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

Public Summary

Page 1 of

Produced at 03.11.2017 at 01:50:11 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.

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