NOX
- 产品代码
- NOX
- 器械名称
- Filler, Bone Void, Synthetic Peptide
- 管理类别
- 第 3 类(Class III)
- FDA 专业组
- Unknown
- 上市路径
- 需 PMA 上市前批准
- 标记
- 属植入器械
- 标记
- 属生命支持/维持器械
FDA 分类定义
The device acts as a bone void filler and consists of a filling material and a synthetic peptide. It is intended to fill traumatic or surgically-created defects that are not intrinsic to the bony structure of the extremities, spine or pelvis. It will be packed or placed into the defect and will resorb over time to be replaced by bone.
FDA 官方分类页: NOX
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。