Australia - English - Department of Health (Therapeutic Goods Administration)
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
PO Box 646,NORTH RYDE, NSW, 2113
ARTG Start Date
Medical Device Class IIb
- 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
Single Device Product
38153 Fixation device, internal, nail, intramedullary, humerus
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.
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.
Page 1 of
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.
Visit www.tga.gov.au for contact information