Bone-screw internal spinal fixation system, sterile

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Disponibil de la:

Nuvasive (Aust/NZ) Pty Ltd

Clasă:

Class IIb

Produs de:

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

Zonă Terapeutică:

61324 - Bone-screw internal spinal fixation system, sterile

Indicații terapeutice:

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.

Statutul autorizaţiei:

A

Data de autorizare:

2020-06-29