Uni-C Cervical Cage System— 510(k) K252774

Substantially Equivalent

ZheJiang Decans Medical Devices Co., Ltd.

FDA 510(k) clearance K252774 for Uni-C Cervical Cage System, Substantially Equivalent on 2026-04-15. Applicant: ZheJiang Decans Medical Devices Co., Ltd..

Clearance details

Applicant: ZheJiang Decans Medical Devices Co., Ltd.
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2025-09-02
Decision date: 2026-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiaxing City, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.