Orthopaedic bone screw, non-bioabsorbable, sterile

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

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Available from:
Zimmer Biomet Pty Ltd
Class 1
Authorization status:
Included (Export Only)
Authorization number:

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Public Summary

Summary for ARTG Entry:


Zimmer Biomet Pty Ltd - Orthopaedic bone screw, non-bioabsorbable, sterile

ARTG entry for

Medical Device Included (Export Only) Class 1


Zimmer Biomet Pty Ltd

Postal Address

Locked Bag 1310,FRENCHS FOREST, NSW, 2086


ARTG Start Date


Product category

Medical Device Class 1



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.




Biomet Trauma

56 East Bell Drive

Warsaw, IN, 46581

United States Of America


1. Orthopaedic bone screw, non-bioabsorbable, sterile

Product Type

Single Device Product

Effective date



46646 Orthopaedic bone screw, non-bioabsorbable, sterile

Intended purpose

Small, threaded non-biodegradable rod with a slotted head typically used for orthopaedic fracture fixation

by being screwed into bone to hold plates or nails in place to provide stabilisation. May also be used to

fasten soft tissue to bone.

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

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Produced at 03.11.2017 at 02:43:32 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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