NRA
- 产品代码
- NRA
- 器械名称
- Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
- 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
This type of device is designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis. It is intended to replace part of a knee joint in order to relieve pain and restore knee function, for indications such as osteoarthritis and avascular necrosis.
FDA 官方分类页： NRA
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。