Cervical total disc replacement prosthesis
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
01-12-2017
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Available from:
Emergo Asia Pacific Pty Ltd T/a Emergo Australia
Class:
Class IIb
Manufactured by:
Signus Medizintechnik GmbH Industriestrasse 2, Alzenau, D-63755 Germany
Therapeutic area:
48164 - Cervical total disc replacement prosthesis
Therapeutic indications:
The device is a disc prosthesis for use in the cervical spine (C3 ? C7). Unlike a cage, in addition to restoring disc height this implant maintains physiological movement. It is used following an anterior approach and cervical discectomy in the following indications: Discopathy, Disc herniation, and Stenosis of the foramen and spinal canal.
Authorization status:
A
Authorization date:
2013-10-31
