NTG

Prosthesis, Ankle, Uncemented, Non-Constrained

产品代码: NTG
器械名称: Prosthesis, Ankle, Uncemented, Non-Constrained
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
标记: 属生命支持/维持器械

FDA 分类定义

An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene.

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）。

FDA 官方分类页： NTG

分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。