Orthopaedic bone screw, non-biodegradable, non-sterile

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

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Available from:
ACRA Regulatory Services Pty Ltd
Class IIb
Authorization status:
Authorization number:

Public Summary

Summary for ARTG Entry:


ACRA Regulatory Services Pty Ltd - Orthopaedic bone screw, non-biodegradable, non-sterile

ARTG entry for

Medical Device Included Class IIb


ACRA Regulatory Services Pty Ltd

Postal Address

7/84 Poincina Avenue,Tewantin, QLD, 4565


ARTG Start Date


Product category

Medical Device Class IIb



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.




Tyber Medical

83 South Commerce Way Suite 310

Bethlehem, Pennsylvania, 18017

United States Of America


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

Product Type

Single Device Product

Effective date



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

Intended purpose

Trauma screw designed to apply compression and fixation between two adjacent segments of cortical

and/or cancellous bone and intended to be for use in bone reconstruction, osteotomy, arthrodesis, joint

fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are

intended for single use only.

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 03:31:09 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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