Cyclops Anterior Cervical Plate System
FDA 510(k) K191786 · Degen Medical, Inc.
510(k) numberK191786
Submission
- Device name
- Cyclops Anterior Cervical Plate System
- Applicant
- Degen Medical, Inc.
Florence, SC, US - Received
- July 3, 2019
- Decision date
- August 30, 2019
- 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
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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 |
|---|---|---|
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | 12/08/2025SE |
| K252737 | DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemODP · Traditional | 10/10/2025SE |
| K250667 | DeGen Medical Patient Specific Implant (PSI) SystemMAX · Special | 04/04/2025SE |
| K241077 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | 10/29/2024SE |
| K240326 | Solar Lumbar Interbody Fusion SystemMAX · Traditional | 07/29/2024SE |
| K231199 | Solar Lumbar Interbody Fusion SystemMAX · Traditional | 06/16/2023SE |
| K223418 | DeGen Impulse AM SystemMAX · Traditional | 03/17/2023SE |
| K213918 | DeGen Navigated InstrumentationOLO · Traditional | 02/09/2022SE |
| K213901 | Cyclops Anterior Cervical Plate SystemKWQ · Special | 01/07/2022SE |
| K210090 | Impulse AM Interbody Fusion SystemMAX · Traditional | 08/30/2021SE |
Questions and answers
When was Cyclops Anterior Cervical Plate System cleared by the FDA?
Cyclops Anterior Cervical Plate System (K191786) received a 510(k) decision of Substantially Equivalent on August 30, 2019, 58 days after the submission was received.
What is the product code of K191786?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.