QVV
- 产品代码
- QVV
- 器械名称
- Medial Knee Implanted Shock Absorber
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 888.3610
- FDA 专业组
- Orthopedic
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属植入器械
- 该代码近三年的 510(k)
- 1 件
FDA 分类定义
A medial knee implanted shock absorber is a device implanted outside of the knee capsule extending from the distal femur to the proximal tibia. It is intended to reduce loads on the intra-articular medial joint surface. The device employs a shock absorbing mechanical system and is biomechanically stabilized by plates and screws. The device is not intended to span the lateral knee.
FDA 官方分类页: QVV
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。