NJA
- 产品代码
- NJA
- 器械名称
- Accessory, System, External Fixator, Containing Antimicrobial Agent
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3040
- FDA 专业组
- Orthopedic
- 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
The device is intended to be used as an accessory surrounding orthopedic pins and wires during external fixation of bones. The sleeve is impregnated with antibiotic (gentamicin) which is released over time in order to inhibit bacterial colonization on the pin/wire.
FDA 官方分类页： NJA
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。