Intramedullary Nail - Femur nail, non-sterile

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

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Available from:
Equinox Orthopaedics Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
324374

Public Summary

Summary for ARTG Entry:

324374

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

ARTG entry for

Medical Device Included Class IIb

Sponsor

Equinox Orthopaedics Pty Ltd

Postal Address

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

Australia

ARTG Start Date

3/10/2019

Product category

Medical Device Class IIb

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Shandong Weigao Orthopaedic Device

Company Limited.

No 26 Xiangjiang Road Tourist Resorts

Weihai City, Shandong, 264203

China

Products

1. Intramedullary Nail - Femur nail, non-sterile

Product Type

Medical device system

Effective date

3/10/2019

GMDN

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 http://www.tga.gov.au/about/website-copyright.htm.

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.

Visit www.tga.gov.au for contact information

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