KWQ
- Product code
- KWQ
- Device name
- Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3060
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 35
- Summaries archived here
- 29 (direct download)
- 510(k) clearances (all years, FDA)
- 667 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (35)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| 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 |
Official FDA classification page: KWQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).