Bone-screw internal spinal fixation system, sterile

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Commercializzato da:

Stryker Australia Pty Ltd

Classe:

Class IIb

Prodotto da:

K2M Inc 600 Hope Parkway SE, Leesburg, Virginia, 20175 United States Of America

Area terapeutica:

61324 - Bone-screw internal spinal fixation system, sterile

Indicazioni terapeutiche:

The Spinal System is a non-cervical, pedicle screw fixation device for posterior stabilization as an adjunct to fusion for the following indications: Trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis of the vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Stato dell'autorizzazione:

A

Data dell'autorizzazione:

2017-09-14