PJM
- 产品代码
- PJM
- 器械名称
- Filler, Bone Void, Alterable Compound For Cranioplasty
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 882.5320
- 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 分类定义
An alterable cranial bone void filler is a device intended to be a bone substitute for the replacement of 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 device is constructed from a material (e.g., calcium, polymer synthetic-based, etc.) that can be reshaped or altered at the time of surgery or after implantation without changing the chemical behavior of the material.
FDA 官方分类页： PJM
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。