Metal-polymer composite spinal fusion cage

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
22-07-2020

から入手可能:

Nuvasive (Aust/NZ) Pty Ltd

クラス:

Class IIb

製:

Nuvasive Inc 7475 Lusk Boulevard, San Diego, CA, 92121 United States Of America

治療領域:

61230 - Metal-polymer composite spinal fusion cage

適応症:

NuVasive interbody system are indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and supplemental internalspinal fixation systems for use in the thoracolumbar spine. The systems are intended for use in interbody fusions in the thoracic spine, from T1 to T12, and at the thoracolumbar junction (T12-L1). The system implants are also intended for use in the lumbar spine, from L1 to S1, for the treatment of symptomatic disc disease or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation The interbody systems can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis. When used in the cervical spine, the interbody implants are indicated for intervertebral body fusion of the spine in skeletally mature patients. The cervical interbody systems are intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and/or cervical spinal instability, that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The system is intended to be used with or without supplemental fixation. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical and/or corticocancellous bone graft to facilitate fusion.

認証ステータス:

A

承認日:

2020-07-14

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