Intramedullary Nail - Femur nail, non-sterile

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

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Equinox Orthopaedics Pty Ltd
Class IIb
Authorization status:
Authorization number:

Public Summary

Summary for ARTG Entry:


Equinox Orthopaedics Pty Ltd - Intramedullary Nail - Femur nail, non-sterile

ARTG entry for

Medical Device Included Class IIb


Equinox Orthopaedics Pty Ltd

Postal Address

28/30 Blues Point Road,McMahons Point, NSW, 2060


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.




Shandong Weigao Orthopaedic Device

Company Limited.

No 26 Xiangjiang Road Tourist Resorts

Weihai City, Shandong, 264203



1. Intramedullary Nail - Femur nail, non-sterile

Product Type

Medical device system

Effective date



56643 Femur nail, non-sterile

Intended purpose

The device acts to immobilize by holding the ends of a fractured femoral bone in position to promote

healing. The device is also used to support the bone in the presence of a pathological condition, or for

knee arthrodesis. This is a single-use device intended to be sterilized prior to use.

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

Public Summary

Page 1 of

Produced at 02.11.2019 at 03:05:13 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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