Memory-alloy
Main information
- Trade name:
- Memory-alloy orthopaedic fixation plate
- Available from:
- Life Healthcare Pty Ltd
- Class:
- Class IIb
- Medicine domain:
- Humans
- Medicine type:
- Medical device
Documents
- for the general public:
- Public Assessment Report
-
- for the general public:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
- for healthcare professionals:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for healthcare professionals.
Localization
- Available in:
-
Australia
- Language:
- English
Other information
Status
- Source:
- Dept. of Health,Therapeutic Goods Administration - Australia
- Authorization number:
- 218346
- Last update:
- 08-10-2017
Public Assessment Report
Public Summary
Summary for ARTG Entry:
218346
Life Healthcare Pty Ltd - Memory-alloy orthopaedic fixation plate
ARTG entry for
Medical Device Included Class IIb
Sponsor
Life Healthcare Pty Ltd
Postal Address
PO Box 646,NORTH RYDE, NSW, 2113
Australia
ARTG Start Date
10/12/2013
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
Biopro Inc
17 Seventeenth Street
PORT HURON, MICHIGAN, 48060
United States Of America
Products
1. Memory-alloy orthopaedic fixation plate
Product Type
Single Device Product
Effective date
10/12/2013
GMDN
58235 Memory-alloy orthopaedic fixation plate
Intended purpose
Hand and foot bone fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones.
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 http://www.tga.gov.au/about/website-copyright.htm.
Public Summary
Page 1 of
Produced at 10.11.2017 at 10:48:15 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
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for the general public.
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