ARIES Anterior Cervical Plate Systems— 510(k) K252776

Substantially Equivalent

ZheJiang 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..

Clearance details

Applicant
ZheJiang Decans Medical Devices Co., Ltd.
Product code
Code KWQ
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Jiaxing City, CN
Download summary PDFView on FDA.gov ↗

Adverse 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.