Polymeric spinal fusion cage, non-sterile

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Kynesis Pty Ltd

Class:

Class IIb

Manufactured by:

CANWELL MEDICAL CO LTD No 466 South Xianhua Street High-Tech Industrial Zone Jinhua, Zhejiang, 321016 China

Therapeutic area:

60762 - Polymeric spinal fusion cage, non-sterile

Therapeutic indications:

The cage is indicated for lumbar and lumbosacral pathologies indicated for segmental arthrodesis in skeletally mature patients, including: degenerative discopathy; primary surgery for advanced discopathies or extensive destabilisation decompressions; revision surgery for failed disc and surgery (i.e. recurrent disc herniation, post-operative instability); lumbar pseudarthrosis, certain lumbar stenosis; degenerative and isthmic spondylolisthesis with grade I residual displacement after reduction.

Authorization status:

A

Authorization date:

2020-11-26