QAD
- 产品代码
- QAD
- 器械名称
- Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3023
- 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
- 该代码近三年的 510(k)
- 7 件
FDA 分类定义
Is a device intended to be implanted that consists of a polymeric balloon that is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures. The balloon is infused with a liquid monomer that causes the balloon to fill the medullary canal of the fractured bone. The device is then exposed to a light source that polymerizes the light-activated monomer within the balloon creating a hardened rigid structure.
该代码近三年的 510(k)（1 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K233436 | 2024-01-19 | Illuminoss Medical, Inc. | IlluminOss Photodynamic Bone Stabilization System 摘要 |
FDA 官方分类页： QAD
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。