OKD
- 产品代码
- OKD
- 器械名称
- Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone Nonunion
- 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
Bone graft substitute when autograft is unavailable or unfeasible to harvest for treatment of recalcitrant long bone non-unions where normal bone metabolism and healing is not present, e.g., smokers and diabetics.
FDA 官方分类页: OKD
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。