QHG
- 产品代码
- QHG
- 器械名称
- Defect Measurement Tool
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 888.4510
- FDA 专业组
- Orthopedic
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 1 件
FDA 分类定义
Manual surgical instrument for appropriate patient select for orthopedic implant is a device used to measure an anatomical feature(s) to determine appropriate patient selection for an orthopedic implant. The characteristics of the instrument are defined by the specifications set for use of the orthopedic implant in terms of geometry, surgical technique, and use of the device.
FDA 官方分类页: QHG
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。