KWQ — Appliance, Fixation, Spinal Intervertebral Body Class II
FDA product code KWQ covers "Appliance, Fixation, Spinal Intervertebral Body", a Class II medical device regulated under 21 CFR 888.3060. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KWQ
- Device Class
- Class II
- Regulation Number
- 888.3060
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261309 | Bethesda Medical Devices | Palisades Buttress Plate System | Jul 16, 2026 |
| K252776 | Zhejiang Decans Medical Devices Co | ARIES Anterior Cervical Plate Systems | May 14, 2026 |
| K261112 | L And K Biomed Co | CastleLoc-P Anterior Cervical Plate System | May 6, 2026 |
| K260570 | Carlsmed | corra cervical plating system | Apr 22, 2026 |
| K260697 | Vy Spine | VyPlate Anterior Cervical Plate System | Mar 27, 2026 |
| K260015 | Spinecraft | ANTERIS Thoracolumbar Plate System | Mar 4, 2026 |
| K251940 | L And K Biomed Co | PathLoc Lumbar Plate System | Mar 3, 2026 |
| K254182 | Osteonic Co | Aster | Feb 26, 2026 |
| K253201 | 4Web | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | Feb 12, 2026 |
| K252611 | Carlsmed | aprevo® cervical plating system | Dec 22, 2025 |
| K251965 | Alphatec Spine | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Aug 28, 2025 |
| K251436 | Pioneer Surgical Technology | Resolve Anterior Cervical Plate System | Jul 11, 2025 |
| K250446 | Spineup | Frida Anterior Cervical Plate System | May 23, 2025 |
| K250602 | Expanding Innovations | X-PAC® N-GAGE Lumbar Plate System | May 20, 2025 |
| K250486 | Kyocera Medical Technologies Inc. (Kmti) | Skyway Anterior Cervical Plate System | Apr 10, 2025 |
| K243904 | Clariance | Elegance® Anterior Cervical plate | Jan 14, 2025 |
| K243369 | Life Spine | Cervical Plating System | Dec 11, 2024 |
| K242361 | Stryker Spine | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal Sy | Nov 7, 2024 |
| K243015 | Kyocera Medical Technologies | Skyway Anterior Cervical Plate System | Nov 5, 2024 |
| K231251 | Jeil Medical Corporation | FlexWing Anterior Cervical Plate System | Jul 24, 2024 |