Cervical Plate System
FDA 510(k) K223753 · Double Medical Technology, Inc.
510(k) numberK223753
Submission
- Device name
- Cervical Plate System
- Applicant
- Double Medical Technology, Inc.
Xiamen, CN - Received
- December 14, 2022
- Decision date
- March 14, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261309 | Palisades Buttress Plate SystemKWQ · Traditional | Bethesda Medical Devices, LLC | 07/16/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/14/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | Vy Spine, LLC | 03/27/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | SpineCraft | 03/04/2026SE |
| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 4Web, Inc. | 02/12/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252729 | Universal Spinal SystemNKB · Traditional | 11/18/2025SE |
| K242348 | Locking Screw,CoCrMoHWC · Abbreviated | 12/04/2024SE |
| K233078 | Posterior Cervical Spine SystemNKG · Traditional | 11/22/2023SE |
| K221150 | Advanced Bone PlateHRS · Traditional | 01/25/2023SE |
| K221088 | Anatomic Bone PlateHRS · Traditional | 01/18/2023SE |
| K221090 | Metal Cannulated ScrewHWC · Traditional | 01/10/2023SE |
| K221221 | Advanced Intramedullary Nail SystemHSB · Traditional | 12/21/2022SE |
| K220921 | Metal Bone ScrewHWC · Traditional | 12/12/2022SE |
| K172830 | Double Medical Femoral Nail SystemHSB · Traditional | 08/24/2018SE |
| K172828 | Double Medical Cage SystemMAX · Traditional | 02/01/2018SE |
Questions and answers
When was Cervical Plate System cleared by the FDA?
Cervical Plate System (K223753) received a 510(k) decision of Substantially Equivalent on March 14, 2023, 90 days after the submission was received.
What is the product code of K223753?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.