Cervical Spine Truss System Plating Solution (CSTS-PS)
FDA 510(k) K212527 · 4Web Medical, Inc.
510(k) numberK212527
Submission
- Device name
- Cervical Spine Truss System Plating Solution (CSTS-PS)
- Applicant
- 4Web Medical, Inc.
Frisco, TX, US - Received
- August 11, 2021
- Decision date
- May 17, 2022
- 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 |
|---|---|---|
| K252834 | Sacroiliac Joint Truss System (SJTS)OUR · Traditional | 01/28/2026SE |
| K253200 | Cervical Spine Truss System - Stand Alone (CSTS-SA)OVE · Traditional | 12/11/2025SE |
| K251117 | Cervical Spine Truss System (CSTS)OVE · Special | 04/25/2025SE |
| K240388 | Osteotomy Truss System (OTS)HRS · Traditional | 11/01/2024SE |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA)OVD · Traditional | 04/22/2024SE |
| K230088 | Ankle Truss System (ATS)SAI · Traditional | 03/21/2024SE |
| K231739 | Cervical Spine Truss System (CSTS)OVE · Traditional | 09/25/2023SE |
| K223362 | Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion DeviceOVE · Traditional | 02/02/2023SE |
| K221266 | Cervical Spine Truss System (CSTS) Interbody Fusion DeviceODP · Traditional | 01/05/2023SE |
| K221283 | Hammertoe Truss System (HTS)HTY · Traditional | 09/06/2022SE |
Questions and answers
When was Cervical Spine Truss System Plating Solution (CSTS-PS) cleared by the FDA?
Cervical Spine Truss System Plating Solution (CSTS-PS) (K212527) received a 510(k) decision of Substantially Equivalent on May 17, 2022, 279 days after the submission was received.
What is the product code of K212527?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.