PJN

Filler, Bone Void, Non-Alterable Compound For Cranioplasty

产品代码

PJN

器械名称

Filler, Bone Void, Non-Alterable Compound For Cranioplasty

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 882.5330

FDA 专业组

Neurology

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)

2 件（全部年份；本站只收录近三年的明细）

FDA 分类定义

A nonalterable cranial bone void filler is a device that is created from patient-specific computerized tomography (CT) imaging data and intended to fill bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The materials used (e.g., metals, polyether ether ketone (PEEK), etc.) in the construction of the nonalterable cranial bone void fillers are not resorbable and cannot be altered or reshaped at the time of surgery or after implantation without changing the chemical behavior of the material.

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）。