Bone tap

Австралия - английски - Department of Health (Therapeutic Goods Administration)

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ACRA Regulatory Services Pty Ltd
Class IIa
Статус Оторизация:
Номер на разрешението:

Public Summary

Summary for ARTG Entry:


ACRA Regulatory Services Pty Ltd - Bone tap

ARTG entry for

Medical Device Included Class IIa


ACRA Regulatory Services Pty Ltd

Postal Address

7/84 Poincina Avenue, Tewantin, QLD, 4565


ARTG Start Date


Product Category

Medical Device Class IIa



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 . Bone tap

Product Type

Single Device Product

Effective Date



17507 Bone tap

Intended Purpose

Surgical instrument intended to be used during implantation of an orthopaedic prosthesis. This is a single use device intended to be

sterilized prior to use.

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

Public Summary

Page 1 of

Produced at 22.07.2020 at 08:22:49 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.

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