Prosthesis, internal, spine, vertebral body

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:

34170 - Prosthesis, internal, spine, vertebral body

Indicazioni terapeutiche:

When used as a thoracolumbar vertebral body replacement device, the system is intended for use in the thoracolumbar spine to replace collapsed, damaged, or unstable vertebral bodies due to tumour or trauma. It is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period. When used as a cervical vertebral body replacement device, the system is intended for use in the cervical spine in skeletally mature patients to replace diseased or damaged vertebral bodies due to tumour, trauma, osteomyelitis, or for reconstruction following corpectomy. The implants are intended to be used with supplemental internal fixation appropriate for the implanted level and may be used with allograft or autograft.

Stato dell'autorizzazione:

A

Data dell'autorizzazione:

2017-07-17