PLW
- 产品代码
- PLW
- 器械名称
- Acetabular Cup Orientation System
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3350
- 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
The acetabular cup orientation system is intended to be used as a surgical instrument to assist in the intra-operative orientation of acetabular cup components used with total hip arthroplasty. The device utilizes anatomic landmarks of the pelvis that are clearly identifiable on pre-operative imaging scans.
FDA 官方分类页： PLW
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。