Fixation device, internal, nail, intramedullary, humerus

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

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Life Healthcare Pty Ltd
Class IIb
Authorization status:
Authorization number:

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Public Summary

Summary for ARTG Entry:


Life Healthcare Pty Ltd - Fixation device, internal, nail, intramedullary, humerus

ARTG entry for

Medical Device Included Class IIb


Life Healthcare Pty Ltd

Postal Address

PO Box 646,NORTH RYDE, NSW, 2113


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.




Nuvasive Specialized Orthopaedics Inc

101 Enterprise Suite 100

Aliso Viejo, CA, 92656

United States Of America


1. Fixation device, internal, nail, intramedullary, humerus

Product Type

Single Device Product

Effective date



38153 Fixation device, internal, nail, intramedullary, humerus

Intended purpose

A single use rod made of metal inserted into the intramedullary canal of the humerus to act as an

immobilization device to hold ends of a fractured bone in position by locking screws and allow dynamic

growth of the 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

Public Summary

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Produced at 03.11.2017 at 02:47:13 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.

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