Prosthesis, internal, spine, vertebral body

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Beli sekarang

Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
01-12-2017

Boleh didapati daripada:

Stryker Australia Pty Ltd

Kelas:

Class IIb

Dikeluarkan oleh:

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

Kawasan terapeutik:

34170 - Prosthesis, internal, spine, vertebral body

Tanda-tanda terapeutik:

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.

Status kebenaran:

A

Tarikh kebenaran:

2017-07-17

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