ARIES Anterior Cervical Plate Systems— 510(k) K252776

Name: FDA 510(k) clearance K252776
Creator: U.S. Food and Drug Administration
Published: 2026-05-14

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.. Device class: 2.

Clearance details

Applicant: ZheJiang Decans Medical Devices Co., Ltd.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2025-09-02
Decision date: 2026-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiaxing City, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWQ

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K261309 — Palisades Buttress Plate System2026-07-16
K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
K260570 — corra cervical plating system2026-04-22
K260697 — VyPlate Anterior Cervical Plate System2026-03-27
K260015 — ANTERIS Thoracolumbar Plate System2026-03-04

More clearances from ZheJiang Decans Medical Devices Co., Ltd.

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K253046 — HERA Interlocking Intramedullary Nailing System2026-06-16
K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems2026-06-02
K252930 — AQUA Laminoplasty Systems2026-05-27
K253130 — Dione PEEK Screw System2026-05-27
K252542 — LEO Spinal System2026-04-29

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.