HSN
- 产品代码
- HSN
- 器械名称
- Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3110
- 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)
- 14 件
- 其中 Summary 已存档
- 12 份，可直接下载
- FDA 历史累计 510(k)
- 68 件（全部年份；本站只收录近三年的明细）
该代码近三年的 510(k)（14 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K253159 | 2026-06-16 | Wright Medical Technology, Inc. (Stryk… | Prophecy Incompass Surgical Planning System | FDA |
| K252454 | 2025-09-03 | Restor3D | Kinos Total Ankle System | |
| K250037 | 2025-06-20 | Wright Medical Technology, Inc. (Stryk… | Incompass Total Ankle System | |
| K250641 | 2025-05-01 | Paragon 28, Inc. | APEX 3D Total Ankle Replacement System | |
| K240475 | 2024-12-02 | Vilex, LLC | Hintermann Series H2 Total Ankle System | |
| K241999 | 2024-11-01 | Wright Medical Technology, Inc. (Stryk… | Prophecy Surgical Planning System | |
| K242868 | 2024-10-18 | Restor3D | Kinos Total Ankle System | |
| K241482 | 2024-07-22 | Restor3D | Kinos Total Ankle System | |
| K240259 | 2024-06-24 | Paragon 28, Inc. | APEX 3D Total Ankle Replacement System | |
| K240591 | 2024-04-29 | Restor3D, Inc. | restor3d Kinos Axiom Total Ankle System | FDA |
| K231699 | 2024-04-23 | In2bones Sas | QUANTUM® Patient Specific Instrumentation (PSI) Syst… | |
| K232595 | 2023-11-28 | Restor3D | Kinos Axiom Total Ankle System | |
| K230717 | 2023-10-12 | Exactech, Inc. | Exactech® Vantage® Total Ankle System | |
| K232002 | 2023-09-11 | Exactech, Inc. | Vantage® Total Ankle System |
FDA 官方分类页： HSN
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。