ARIES Anterior Cervical Plate Systems— 510(k) K252776
Substantially EquivalentZheJiang Decans Medical Devices Co., Ltd.
FDA 510(k) clearance K252776 for ARIES Anterior Cervical Plate Systems, Substantially Equivalent on 2026-05-14. Applicant: ZheJiang Decans Medical Devices Co., Ltd.. Device class: 2.
Summary
ZheJiang Decans Medical Devices' ARIES Anterior Cervical Plate Systems are filed under KWQ, spinal intervertebral body fixation appliances.
Class II, 21 CFR 888.3060. Orthopedic is both the classification panel and the review panel, and it was a Traditional 510(k).
Decans filed from Jiaxing City, China. The decision came 254 calendar days after receipt (September 2, 2025 to May 14, 2026).
Clearance details
- Applicant
- ZheJiang Decans Medical Devices Co., Ltd.
- Product code
- Product code KWQ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3060
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jiaxing City, CN
Recent devices under product code KWQ
view allMore clearances from ZheJiang Decans Medical Devices Co., Ltd.
view allAdverse events under product code KWQ
product code KWQ- Death
- 8
- Injury
- 1,212
- Malfunction
- 1,233
- Total
- 2,453
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.