Polymeric spinal fusion cage, non-sterile
Access comprehensive regulatory information for Polymeric spinal fusion cage, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Kynesis Pty Ltd, manufactured by CANWELL MEDICAL CO LTD in China. The device registration started on November 26, 2020.
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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.