Spinal fixation plate, non-biodegradable
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
28-05-2020
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Available from:
Prism Surgical Designs Pty Ltd
Class:
Class IIb
Manufactured by:
PSM Pacific Pty Ltd 15/43 Lang Parade, MILTON, QLD, 4064 Australia
Therapeutic area:
46653 - Spinal fixation plate, non-biodegradable
Therapeutic indications:
The device is a spinal fusion device designed to promote arthrodesis at one paired motion segment and is intended for use in the lumbar spine (L2-S1). The device is designed to restore stabililty and increase rigidity of one lumbar motion segment after total discectomy of the intervertebral disc and placement of an interbody fusion device (with graft material) to achieve a solid arthrodesis via an anterior or anterolateral surgical approach.
Authorization status:
A
Authorization date:
2020-05-06
