OMX

High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis

产品代码

OMX

器械名称

High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis

管理类别

第 F 类（HDE）

FDA 专业组

Unknown

上市路径

HDE - Humanitarian Device Exemption

标记

属植入器械

FDA 分类定义

For use in arthroplasty of the proximal interphalangeal (PIP) joint when the patient: a) has soft tissue and bone that can provide adequate stabilization and fixation under high-demand loading conditions after reconstruction; and b) needs a revision of a failed PIP prosthesis, or has pain, limited motion, or joint subluxation/disloation secondary to damage or destruction of the articular cartilage.

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）。