Prosthesis, internal, spine, vertebral body

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Disponibil de la:

Stryker Australia Pty Ltd

Clasă:

Class IIb

Produs de:

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

Zonă Terapeutică:

34170 - Prosthesis, internal, spine, vertebral body

Indicații terapeutice:

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.

Statutul autorizaţiei:

A

Data de autorizare:

2017-07-17