Prosthesis, internal, spine, vertebral body

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

现在购买

公众评估报告 公众评估报告 (PAR)
01-12-2017

可用日期:

Stryker Australia Pty Ltd

类:

Class IIb

厂商:

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

治疗领域:

34170 - Prosthesis, internal, spine, vertebral body

疗效迹象:

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.

授权状态:

A

授权日期:

2017-07-17

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