QZZ

Limb And Joint Salvage Device With Coating For Bacteria Reduction

产品代码

QZZ

器械名称

Limb And Joint Salvage Device With Coating For Bacteria Reduction

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 888.3900

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)

3 件

FDA 分类定义

A limb and joint salvage device with quaternary ammonium compound coating is a metallic implant with or without polymer bearing for bone and joint replacement. Implants are for resection and replacement of an extremity bone (including the entire bone, epiphyseal bone, metaphyseal bone, or diaphyseal bone), or an extremity bone and the surrounding joint(s) in a skeletally mature patient. The device includes a quaternary ammonium compound coating that is covalently bonded to the device. Where applied, the coating is intended to reduce microbial contamination on the surface of the device prior to implantation. The device does not contain antimicrobial agents that act within or on the body and this device type does not include combination products.

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）。

该代码近三年的 510(k)（3 件）

数据窗口为最近三年。最新一件：2026-06-08。

其中 2 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。