OJP

Orthopedic Computer Controlled Surgical System

产品代码

OJP

器械名称

Orthopedic Computer Controlled Surgical System

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 882.4560

FDA 专业组

Neurology

上市路径

需提交 510(k) 上市前通告

FDA 历史累计 510(k)

4 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision. Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).

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）。