QKW

Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis

产品代码

QKW

器械名称

Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 888.3695

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

FDA 历史累计 510(k)

1 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials, such as pyrolytic carbon,and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement (§ 888.3027). This device is not intended for use in total shoulder arthroplasty.

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）。