Metal-polymer composite spinal fusion cage

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgjengelig fra:

Nuvasive (Aust/NZ) Pty Ltd

Klasse:

Class IIb

Produsert av:

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

Terapeutisk område:

61230 - Metal-polymer composite spinal fusion cage

Indikasjoner:

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.

Autorisasjon status:

A

Autorisasjon dato:

2020-07-14