Orthopaedic bone screw, non-biodegradable, non-sterile

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

Buy It Now

Available from:
ACRA Regulatory Services Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
324190

Public Summary

Summary for ARTG Entry:

324190

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

ARTG entry for

Medical Device Included Class IIb

Sponsor

ACRA Regulatory Services Pty Ltd

Postal Address

7/84 Poincina Avenue,Tewantin, QLD, 4565

Australia

ARTG Start Date

27/09/2019

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

Tyber Medical

83 South Commerce Way Suite 310

Bethlehem, Pennsylvania, 18017

United States Of America

Products

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

Product Type

Single Device Product

Effective date

27/09/2019

GMDN

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

Search alerts related to this product

Share this information