Orthopaedic bone screw, non-biodegradable, non-sterile

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

Buy It Now

Available from:
LMT Surgical Pty Ltd
Class:
Class 1
Authorization status:
Included (Export Only)
Authorization number:
323587

Public Summary

Summary for ARTG Entry:

323587

LMT Surgical Pty Ltd - Orthopaedic bone screw, non-biodegradable, non-sterile

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

LMT Surgical Pty Ltd

Postal Address

PO Box 41,PADDINGTON, QLD, 4064

Australia

ARTG Start Date

16/09/2019

Product category

Medical Device Class 1

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

Field Orthopaedics Pty Ltd

375 Wickham Terrace

Spring Hill, QLD, 4000

Australia

Products

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

Product Type

Single Device Product

Effective date

16/09/2019

GMDN

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

Intended purpose

Screws for use in orthopaedic surgeries for correction of fractures or other bone related disorders

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 04:14:46 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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