Vertebron SCP Cervical Plate System
FDA 510(k) K040003 · Vertebron, Inc.
510(k) numberK040003
Submission
- Device name
- Vertebron SCP Cervical Plate System
- Applicant
- Vertebron, Inc.
Stratford, CT, US - Received
- January 2, 2004
- Decision date
- March 26, 2004
- 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 |
|---|---|---|
| K081567 | Vertebron SSP Cervical Plating SystemKWQ · Special | 07/03/2008SE |
| K081597 | Modification to Vertebron PSS Pedicle Screw SystemMNI · Special | 07/02/2008SE |
| K073502 | Vertebron VBR SystemMQP · Traditional | 03/24/2008SE |
| K071376 | Modification to Vertebron PSS Pedicle Screw SystemNKB · Special | 06/13/2007SE |
| K062110 | Vertebron SCP Cervical Plate SystemKWQ · Special | 08/16/2006SE |
| K051815 | Modification to Vertebron SCP Cervical Plate SystemKWQ · Special | 10/17/2005SE |
| K051716 | Vertebron PSS Pedicle Screw SystemKWP · Special | 09/07/2005SE |
| K043152 | Vertebron PSS Pedicle Screw SystemMNH · Special | 02/01/2005SE |
| K043181 | Modification to Vertebron SCP Cervical Plate SystemKWQ · Special | 12/17/2004SE |
| K033352 | Vertebron PSS Pedicle Screw SystemMNI · Traditional | 02/25/2004SE |
Questions and answers
When was Vertebron SCP Cervical Plate System cleared by the FDA?
Vertebron SCP Cervical Plate System (K040003) received a 510(k) decision of Substantially Equivalent on March 26, 2004, 84 days after the submission was received.
What is the product code of K040003?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.