Prosthesis, internal, spine, vertebral body

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Tilgjengelig fra:

Stryker Australia Pty Ltd

Klasse:

Class IIb

Produsert av:

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

Terapeutisk område:

34170 - Prosthesis, internal, spine, vertebral body

Indikasjoner:

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.

Autorisasjon status:

A

Autorisasjon dato:

2017-07-17