NHB
- 产品代码
- NHB
- 器械名称
- Polymer, Ear, Nose And Throat, Synthetic, Absorbable
- 管理类别
- 第 2 类(Class II)
- 21 CFR 条款
- 21 CFR 874.3620
- FDA 专业组
- Ear, Nose, Throat
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 3 件
- 其中 Summary 已存档
- 3 份,可直接下载
- FDA 历史累计 510(k)
- 16 件(全部年份;本站只收录近三年的明细)
FDA 分类定义
Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.
该代码近三年的 510(k)(3 件)
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K260620 | 2026-07-30 | Spirair, Inc. | SeptAlign (SPLN001) | |
| K251790 | 2026-01-16 | Spirair, Inc. | SeptAlign | |
| K233569 | 2024-03-22 | Spirair, Inc. | SeptAlign |
FDA 官方分类页: NHB
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。