ARIES Anterior Cervical Plate Systems
FDA 510(k) K252776 · ZheJiang Decans Medical Devices Co., Ltd.
510(k) numberK252776
Submission
- Device name
- ARIES Anterior Cervical Plate Systems
- Applicant
- ZheJiang Decans Medical Devices Co., Ltd.
Jiaxing City, CN - Received
- September 2, 2025
- Decision date
- May 14, 2026
- 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 |
| 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 |
| K251965 | Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)KWQ · Traditional | Alphatec Spine, Inc. | 08/28/2025SE |
More from Alphatec Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | 06/16/2026SE |
| K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsNKG · Traditional | 06/02/2026SE |
| K253130 | Dione PEEK Screw SystemMBI · Traditional | 05/27/2026SE |
| K252930 | AQUA Laminoplasty SystemsNQW · Traditional | 05/27/2026SE |
| K252542 | LEO Spinal SystemNKB · Traditional | 04/29/2026SE |
| K253213 | SAGI Cervical Cage SystemOVE · Traditional | 04/20/2026SE |
| K252774 | Uni-C Cervical Cage SystemOVE · Traditional | 04/15/2026SE |
| K243665 | Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System…MBI · Traditional | 01/31/2025SE |
| K242195 | Gemini Cervical Fusion Cage SystemODP · Traditional | 11/04/2024SE |
| K242267 | Gemini Medical Cage SystemMAX · Traditional | 10/08/2024SE |
Questions and answers
When was ARIES Anterior Cervical Plate Systems cleared by the FDA?
ARIES Anterior Cervical Plate Systems (K252776) received a 510(k) decision of Substantially Equivalent on May 14, 2026, 254 days after the submission was received.
What is the product code of K252776?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.