Summary for ARTG Entry:
Matrix Medical Innovations Pty Ltd - Spinal fixation plate, non-biodegradable
ARTG entry for
Medical Device Included Class IIb
Matrix Medical Innovations Pty Ltd
Unit 10 / 9-11 Myrtle Street,CROWS NEST DC, NSW, 2065
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.
A-Spine Asia Co Ltd
11F No 1 Alley 30 Lane 358 Ruiguang Road
Neihu District, Tapei,
Taiwan (Province of China)
1. Spinal fixation plate, non-biodegradable
Medical device system
46653 Spinal fixation plate, non-biodegradable
Plate System intended for anterior screw fixation to the cervical spine, thoracic or thoracolumbar
verterbrae. Indicated for use in the temporary stabilization of the anterior spine during the development of
cervical spinal fusion in patients with; degenerative disc disease (as defined by neck pain of discogenic
origin with degeneration of the disc confirmed by patient history and radiographic studies),
spondylolisthesis, trauma (i.e., fractures or dislocations), tumours, deformity (defined as kyphosis, lordosis,
or scoliosis), pseudoarthrosis, and/or failed previous fusions. May also be indicated in situations of
unstable thoracic, thoracolumbar and lumbar spinal problems. It is recommended to immobilize short
segments (less than 5 segments) of spine after anterior interbody fusion from the thoracic vertebrae to the
lower lumbar vertebrae.
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 10.11.2017 at 10:26:35 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