KWQ
- 产品代码
- KWQ
- 器械名称
- Appliance, Fixation, Spinal Intervertebral Body
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 888.3060
- 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)
- 35 件
- 其中 Summary 已存档
- 29 份，可直接下载
- FDA 历史累计 510(k)
- 667 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)（35 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| K261309 | 2026-07-16 | Bethesda Medical Devices, LLC | Palisades Buttress Plate System | |
| K252776 | 2026-05-14 | ZheJiang Decans Medical Devices Co., L | ARIES Anterior Cervical Plate Systems | |
| K261112 | 2026-05-06 | L&K BIOMED Co., Ltd. | CastleLoc-P Anterior Cervical Plate System | FDA |
| K260570 | 2026-04-22 | Carlsmed, Inc. | corra cervical plating system | |
| K260697 | 2026-03-27 | Vy Spine, LLC | VyPlate Anterior Cervical Plate System | FDA |
| K260015 | 2026-03-04 | SpineCraft | ANTERIS Thoracolumbar Plate System | |
| K251940 | 2026-03-03 | L&K BIOMED Co., Ltd. | PathLoc Lumbar Plate System | |
| K254182 | 2026-02-26 | Osteonic Co., Ltd. | Aster | |
| K253201 | 2026-02-12 | 4Web, Inc. | Lumbar Spine Truss System - Plating Solution (LSTS-P | |
| K252611 | 2025-12-22 | Carlsmed, Inc. | aprevo® cervical plating system | |
| K251965 | 2025-08-28 | Alphatec Spine, Inc. | Proximity Anterior Cervical Plate System; Segmental | |
| K251436 | 2025-07-11 | Pioneer Surgical Technology, Inc. | Resolve Anterior Cervical Plate System | |
| K250446 | 2025-05-23 | Spineup, Inc. | Frida Anterior Cervical Plate System | |
| K250602 | 2025-05-20 | Expanding Innovations, Inc. | X-PAC® N-GAGE Lumbar Plate System | |
| K250486 | 2025-04-10 | Kyocera Medical Technologies Inc. (KMT | Skyway Anterior Cervical Plate System | |
| K243904 | 2025-01-14 | Clariance | Elegance® Anterior Cervical plate | |
| K243369 | 2024-12-11 | Life Spine, Inc. | Cervical Plating System | |
| K242361 | 2024-11-07 | Stryker Spine | OZARK Cervical Plate System; PYRENEES® Cervical Plat | FDA |
| K243015 | 2024-11-05 | Kyocera Medical Technologies, Inc. | Skyway Anterior Cervical Plate System | |
| K231251 | 2024-07-24 | Jeil Medical Corporation | FlexWing Anterior Cervical Plate System | |
| K240592 | 2024-05-24 | Spinal Simplicity, LLC | Wolff's Law Anterior Cervical Plate System | |
| K241175 | 2024-05-17 | MiRus, LLC | MiRus MoRe Lumbar Plating System | |
| K233215 | 2024-05-17 | Icotec AG | icotec Anterior Cervical Plate System | |
| K240935 | 2024-05-17 | Effortmed, LLC | ARENAL Anterior Cervical Plate System | |
| K240484 | 2024-04-17 | Mikron Makina Sanayi VE Ticaret Ltd. S | MSFX Mikron Cervical Anterior Plate System | FDA |
| K232256 | 2024-04-16 | Camber Spine Technologies, LLC | Alcantara Thoracolumbar Plate System | |
| K240423 | 2024-04-08 | Tdm Co., Ltd. | TDM Anterior Cervical Plate System | |
| K240690 | 2024-03-22 | Nexxt Spine | STRUXXURE® MCS Anterior Cervical Plate System | |
| K240515 | 2024-03-18 | Ulrich Medical USA, Inc. | uNion® MAX Cervical Plate System | |
| K233360 | 2024-02-29 | Curiteva, Inc. | Curiteva Thoracolumbar Plate System | FDA |
| K233640 | 2024-02-22 | Alphatec Spine, Inc. | Segmental Plating System (SPS);IdentiTi SPS Interbod | FDA |
| K231715 | 2024-01-26 | Ctl Medical Corporation | MONDRIAN Anterior Lumbar Plate System | |
| K233735 | 2024-01-25 | Globus Medical, Inc. | ADIRA Lateral Plate System | |
| K232318 | 2023-10-31 | Globus Medical, Inc. | VICTORY Lumbar Plate System | |
| K231766 | 2023-09-12 | Kyocera Medical Technologies Inc. (KMT | Skyway Anterior Cervical Plate System |
FDA 官方分类页： KWQ
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。