Orthopaedic bone screw, non-biodegradable, non-sterile

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

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Available from:
Southern Cross Surgical Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
339424

Public Summary

Summary for ARTG Entry:

339424

Southern Cross Surgical Pty Ltd - Orthopaedic bone screw, non-biodegradable, non-sterile

ARTG entry for

Medical Device Included Class IIb

Sponsor

Southern Cross Surgical Pty Ltd

Postal Address

PO Box 56, St Ives, NSW, 2075

Australia

ARTG Start Date

13/07/2020

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

Jiangsu Shuangyang Medical Instrument Co Ltd

Shuangyang Building Baoji

Zhangjiagang, Jiangsu, 215600

China

Products

1 . Orthopaedic bone screw, non-biodegradable, non-sterile

Product Type

Single Device Product

Effective Date

13/07/2020

GMDN

56642 Orthopaedic bone screw, non-biodegradable, non-sterile

Intended Purpose

Titanium bone screw used for cranial, maxillofacial, clavicle, limb diaphyseal and epiphyseal, pelvic, metacarpal and phalange, and

calcaneus fractures.

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

Page 1 of

Produced at 22.07.2020 at 09:31:53 AEST

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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