Bone-screw internal spinal fixation system, sterile

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Disponible desde:

Nuvasive (Aust/NZ) Pty Ltd

clase:

Class IIb

Fabricado por:

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

Área terapéutica:

61324 - Bone-screw internal spinal fixation system, sterile

indicaciones terapéuticas:

A thoracolumbar and sacral pedicle screw system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of Degenerative disc disease. Spondylolisthesis, Fracture, Dislocation, Spinal deformities, Spinal tumor and/or Failed previous fusion (pseudoarthrosis). When used as an anterolateral non-pedicle screw system in the thoracolumbar spine, it is also intended for the same indications listed above. Its also indicated for the treatment of severe spondylolisthesis of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft. When used for posterior non-cervical screw fixation in pediatric patients, it is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis, spondylolisthesis / spondylolysis, and fracture caused by tumor and/or trauma.

Estado de Autorización:

A

Fecha de autorización:

2020-06-29