Product code KWQ
Current FDA Classification
- Device name
- Appliance, Fixation, Spinal Intervertebral Body
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3060
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252776 | ARIES Anterior Cervical Plate Systems | ZheJiang Decans Medical Devices Co., Ltd. | 2026-05-14 |
| K261112 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | 2026-05-06 |
| K260570 | corra cervical plating system | Carlsmed, Inc. | 2026-04-22 |
| K260697 | VyPlate Anterior Cervical Plate System | Vy Spine, LLC | 2026-03-27 |
| K260015 | ANTERIS Thoracolumbar Plate System | SpineCraft | 2026-03-04 |
| K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | 2026-03-03 |
| K254182 | Aster | Osteonic Co., Ltd. | 2026-02-26 |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | 2026-02-12 |
| K252611 | aprevo® cervical plating system | Carlsmed, Inc. | 2025-12-22 |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) | Alphatec Spine, Inc. | 2025-08-28 |
| K251436 | Resolve Anterior Cervical Plate System | Pioneer Surgical Technology, Inc. | 2025-07-11 |
| K250446 | Frida Anterior Cervical Plate System | Spineup, Inc. | 2025-05-23 |
| K250602 | X-PAC® N-GAGE Lumbar Plate System | Expanding Innovations, Inc. | 2025-05-20 |
| K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025-04-10 |
| K243904 | Elegance® Anterior Cervical plate | Clariance | 2025-01-14 |
| K243369 | Cervical Plating System | Life Spine, Inc. | 2024-12-11 |
| K242361 | OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI | Stryker Spine | 2024-11-07 |
| K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024-11-05 |
| K231251 | FlexWing Anterior Cervical Plate System | Jeil Medical Corporation | 2024-07-24 |
| K240592 | Wolff's Law Anterior Cervical Plate System | Spinal Simplicity, LLC | 2024-05-24 |
| K240935 | ARENAL Anterior Cervical Plate System | Effortmed, LLC | 2024-05-17 |
| K233215 | icotec Anterior Cervical Plate System | Icotec AG | 2024-05-17 |
| K241175 | MiRus MoRe Lumbar Plating System | MiRus, LLC | 2024-05-17 |
| K240484 | MSFX Mikron Cervical Anterior Plate System | Mikron Makina Sanayi VE Ticaret Ltd. Sti. | 2024-04-17 |
| K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 2024-04-16 |
| K240423 | TDM Anterior Cervical Plate System | Tdm Co., Ltd. | 2024-04-08 |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate System | Nexxt Spine | 2024-03-22 |
| K240515 | uNion® MAX Cervical Plate System | Ulrich Medical USA, Inc. | 2024-03-18 |
| K233360 | Curiteva Thoracolumbar Plate System | Curiteva, Inc. | 2024-02-29 |
| K233640 | Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System | Alphatec Spine, Inc. | 2024-02-22 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000663322 | ZEVO™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-19 |
| 00763000663360 | ZEVO™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-19 |
| 00840283402197 | VyPlate™ | VY SPINE LLC | 2026-03-19 |
| 00840283402203 | VyPlate™ | VY SPINE LLC | 2026-03-19 |
| 08800071055440 | ASTER | OSTEONIC CO.,Ltd. | 2026-03-19 |
| 00763000663315 | ZEVO™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-19 |
| 00763000890100 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890216 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890117 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890124 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890131 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890148 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890155 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890162 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890179 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890186 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890193 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890209 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890094 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890087 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890070 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890063 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890056 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890049 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890032 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890025 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890018 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000890001 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000889999 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |
| 00763000889982 | VENTURE™ Anterior Cervical Plate System | MEDTRONIC SOFAMOR DANEK, INC. | 2026-03-16 |