NXT

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

产品代码

NXT

器械名称

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

管理类别

第 3 类（Class III）

FDA 专业组

Unknown

上市路径

需 PMA 上市前批准

标记

属植入器械

FDA 分类定义

Prosthesis, hip, semi-constrained, metal/metal, resurfacing device relieves hip pain and improves hip function by replacing the parts of the hip that have been severely damaged by degenerative joint diseases. This device is indicated for patients with degenerative joint diseases including osteoarthritis, rheumatoid arthritis, traumatic arthritis, dysplasia, or avascular necrosis and for patients who, due to their relatively younger age or increased activity level, may not be suitable for traditional total hip replacement due to an increased possibility of requiring future hip joint revision.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。