Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System
FDA 510(k) K024326 · Spinal Concepts, Inc.
510(k) numberK024326
Submission
- Device name
- Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System
- Applicant
- Spinal Concepts, Inc.
Austin, TX, US - Received
- December 26, 2002
- Decision date
- January 23, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K051000 | Fortitude Vue Vertebral Body Replacement DeviceMQP · Special | 05/19/2005SE |
| K050706 | Harmony Port System, Model 1907 SeriesGZT · Traditional | 04/15/2005SE |
| K040096 | Spinal Concepts, Inc. Tandem Spinous Process Plate SystemKWP · Traditional | 07/01/2004SE |
| K033663 | Spinal Concepts Inc. CodaMQP · Traditional | 05/27/2004SE |
| K033517 | Spinal Concepts Inc. Cadence and TraxisMQP · Special | 02/18/2004SE |
| K031855 | Spinal Concepts, Inc. Insight Pedicle Screw SystemKWQ · Traditional | 09/17/2003SE |
| K031985 | Spinal Concepts Inc. Nex-Link Spinal Fixation SystemMNI · Traditional | 09/11/2003SE |
| K031318 | Traxis Cement RestrictorJDK · Special | 08/22/2003SESU |
| K031672 | Spinal Concepts, Inc. Infix SystemMQP · Traditional | 08/07/2003SE |
| K031837 | Modification to Fortitude Cement RestrictorJDK · Special | 07/24/2003SE |
Questions and answers
When was Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System cleared by the FDA?
Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System (K024326) received a 510(k) decision of Substantially Equivalent on January 23, 2003, 28 days after the submission was received.
What is the product code of K024326?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.