Fixation system, internal, spinal, bone screw

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

Nuvasive (Aust/NZ) Pty Ltd

Klass:

Class IIb

Tillverkad av:

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

Terapiområde:

43257 - Fixation system, internal, spinal, bone screw

Terapeutiska indikationer:

The NuVasive Systems are intended to provide immobilisation and stabilisation of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and/or failed previous fusion (pseudoarthrosis). The NuVasive Systems are also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

Bemyndigande status:

A

Tillstånd datum:

2013-05-06