Fixation system, internal, spinal, bone screw

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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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:

43257 - Fixation system, internal, spinal, bone screw

Therapeutic indications:

The pedicle screw and fixation rod system is indicated for stabilisation of the spine until stability has been achieved in patients who have undergone surgical fusion of the spine. Indications for all pedicle screw systems: Instability of the spine or deviations from the normal position of the spine, Fractures, Postoperative or degenerative instability, Tumours and spondylodiscitis, Correction of Meyerding grade 1 spondylolisthesis, Disc prolapse, Stenoses of the lumbar spine, Disc resection, Abnormal lordosis/kyphosis/scoliosis and Degenerative segmental disease. The system is furthermore indicated in situations where external immobilisation by means of a plaster cast or splint is not possible.

Authorization status:

A

Authorization date:

2013-10-31

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