Orthopaedic bone pin, non-bioabsorbable

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

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Available from:
Australian Pacific Medical Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
322423

Public Summary

Summary for ARTG Entry:

322423

Australian Pacific Medical Pty Ltd - Orthopaedic bone pin, non-bioabsorbable

ARTG entry for

Medical Device Included Class IIb

Sponsor

Australian Pacific Medical Pty Ltd

Postal Address

1 Clanalpine Street,EASTWOOD, NSW, 2122

Australia

ARTG Start Date

28/08/2019

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

Aike (Shanghai) Medical Instrument Co Ltd

East Area No 125 Longpan Road

Malu Town Jading District, Shanghai, 201801

China

Products

1. Orthopaedic bone pin, non-bioabsorbable

Product Type

Single Device Product

Effective date

28/08/2019

GMDN

32854 Orthopaedic bone pin, non-bioabsorbable

Intended purpose

Bfix Bone Pins are intended to be used for long and small bone fixation. They are available in different

thread designs, thread and shaft diameters and lengths, hydroxy-apatite coated and uncoated in order to

be applied according to the anatomical site (i.e. upper limb, lower limb, pelvis, hand and foot), bone

dimensions and quality, and soft tissue dimensions. They are available in stainless steel and titanium.

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 05:47:31 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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