Fixation system, internal, spinal, bone screw
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
09-11-2017
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Available from:
Medtronic Australasia Pty Ltd
Class:
Class IIb
Manufactured by:
Medtronic Sofamor Danek USA Inc 1800 Pyramid Place, Memphis, Tennessee, 38132 United States Of America
Therapeutic area:
43257 - Fixation system, internal, spinal, bone screw
Therapeutic indications:
Intended for correction and maintenance of multi-planar spinal deformities associated with severe, progressive, and early-onset scoliosis. The device is designed to help attain spinal correction while allowing continued skeletal growth.
Authorization status:
A
Authorization date:
2014-03-03
