MRW
- 产品代码
- MRW
- 器械名称
- System, Facet Screw Spinal Device
- 管理类别
- 第 U 类（Unclassified）
- FDA 专业组
- Unknown
- 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)
- 20 件
- 其中 Summary 已存档
- 19 份，可直接下载
- FDA 历史累计 510(k)
- 78 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)（20 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261209 | 2026-06-11 | SurGenTec, LLC | Ion-L | |
| K253676 | 2026-05-14 | Providence Medical Technology, Inc. | CORUS Posterior Cervical Stabilization System 3D (C… | |
| K253432 | 2026-03-19 | Vy Spine, LLC | DiversiVy Facet Screw System | |
| K251714 | 2026-01-16 | SurGenTec, LLC | Ion-C | |
| K250679 | 2025-12-04 | Sc Medica | FFX Facet Fixation System | |
| K253190 | 2025-11-20 | Providence Medical Technology, Inc. | CORUS-LX Implant | |
| K252153 | 2025-10-16 | Sc Medica | FFX Facet Fixation System | |
| K251885 | 2025-07-10 | Providence Medical Technology, Inc. | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX… | FDA |
| K250920 | 2025-05-22 | Arthrex, Inc. | Arthrex Spine Compression FT Screw | |
| K242527 | 2025-05-21 | Spinal Elements, Inc. | The Karma® Fixation System | |
| K243865 | 2025-03-24 | Aurora Spine | AERO MIS Facet Fusion System | |
| K243265 | 2024-12-04 | SurGenTec, LLC | Ion 3D | |
| K242650 | 2024-09-20 | Zygofix , Ltd. | zLOCK Lumbar Facet Fixation System | |
| K241035 | 2024-06-25 | Providence Medical Technology, Inc. | PMT Posterior Cervical Stabilization System (PCSS) | |
| K241416 | 2024-06-17 | SurGenTec, LLC | Ion 3D | |
| K232468 | 2024-05-09 | Sc Medica | SC Medica FFX | |
| K240085 | 2024-04-18 | Zygofix , Ltd. | zLOCK Lumbar Facet Fixation System | |
| K240086 | 2024-02-08 | SurGenTec, LLC | Ion 3D | |
| K230840 | 2023-12-19 | Providence Medical Technology, Inc. | PMT Facet Fixation System, Lumbar (PMT FFS-LX) | |
| K232877 | 2023-12-13 | K&J Consulting Corporation | FaSet Fixation System, UNITY Sacroiliac Joint Fixati… |
FDA 官方分类页： MRW
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。