Prosthesis, internal, spine, vertebral body

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
01-12-2017

から入手可能:

Stryker Australia Pty Ltd

クラス:

Class IIb

製:

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

治療領域:

34170 - Prosthesis, internal, spine, vertebral body

適応症:

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.

認証ステータス:

A

承認日:

2017-07-17

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