Athena Cervical Plate System
FDA 510(k) K180022 · Medyssey USA, Inc.
510(k) numberK180022
Submission
- Device name
- Athena Cervical Plate System
- Applicant
- Medyssey USA, Inc.
Elk Grove Village, IL, US - Received
- January 3, 2018
- Decision date
- July 20, 2018
- 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 |
|---|---|---|
| K232218 | Zenius Spinal SystemNKB · Special | 08/24/2023SE |
| K230301 | Athena III Cervical Plate SystemKWQ · Special | 03/07/2023SE |
| K223654 | Medussa-PL CageMAX · Special | 12/28/2022SE |
| K200283 | Medussa-PL CageMAX · Special | 06/18/2020SE |
| K183407 | Triton CageMAX · Traditional | 08/30/2019SE |
| K183409 | Athena II Cervical Plate SystemKWQ · Traditional | 02/11/2019SE |
| K181978 | Zenius, Iliad and Kora Spinal Fixation SystemsNKB · Special | 08/13/2018SE |
| K170389 | TAURUS PEEK Cage SystemMAX · Traditional | 12/14/2017SE |
| K172756 | Varian cageMAX · Traditional | 12/08/2017SE |
| K170341 | Medussa-PL CageMAX · Traditional | 11/02/2017SE |
Questions and answers
When was Athena Cervical Plate System cleared by the FDA?
Athena Cervical Plate System (K180022) received a 510(k) decision of Substantially Equivalent on July 20, 2018, 198 days after the submission was received.
What is the product code of K180022?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.