QVV

Medial Knee Implanted Shock Absorber

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.

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: 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。