Eagle Anterior Cervial Plate System
FDA 510(k) K040197 · Depuyacromed
510(k) numberK040197
Submission
- Device name
- Eagle Anterior Cervial Plate System
- Applicant
- Depuyacromed
Raynham, MA, US - Received
- January 29, 2004
- Decision date
- April 2, 2004
- 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
| 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 |
|---|---|---|
| K031635 | Depuy Acromed VBR SystemMQP · Special | 06/23/2003SE |
| K030833 | Depuy Acromed VBR SystemMQP · Special | 04/10/2003SE |
| K030383 | Modification to Moss Miami Spinal System Polyaxial ScrewsMNH · Special | 02/26/2003SE |
| K030249 | Surgical Titanium Mesh SystemMQP · Special | 02/14/2003SE |
| K030103 | Summit Oct Spinal System Minipolyaxial ScrewsMNI · Special | 02/05/2003SE |
| K023835 | Devex Mesh SystemMQP · Special | 01/29/2003SE |
| K024348 | Monarch Spine SystemMNH · Special | 01/28/2003SE |
| K023804 | Moss Miami Spinal System Pin NutKWP · Special | 01/23/2003SE |
| K021039 | Bowti Anterior Buttress Staple SystemKWQ · Traditional | 12/11/2002SE |
| K023438 | Modification to Monarch Spine SystemMNH · Special | 11/13/2002SE |
Questions and answers
When was Eagle Anterior Cervial Plate System cleared by the FDA?
Eagle Anterior Cervial Plate System (K040197) received a 510(k) decision of Substantially Equivalent on April 2, 2004, 64 days after the submission was received.
What is the product code of K040197?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.