Dione PEEK Screw System— 510(k) K253130

Substantially Equivalent

ZheJiang Decans Medical Devices Co., Ltd.

FDA 510(k) clearance K253130 for Dione PEEK Screw System, Substantially Equivalent on 2026-05-27. Applicant: ZheJiang Decans Medical Devices Co., Ltd..

Clearance details

Applicant: ZheJiang Decans Medical Devices Co., Ltd.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2025-09-25
Decision date: 2026-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiaxing, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.