Cervical Plate System— 510(k) K223753

Name: FDA 510(k) clearance K223753
Creator: U.S. Food and Drug Administration
Published: 2023-03-14

Substantially Equivalent

Double Medical Technology, Inc.

FDA 510(k) clearance K223753 for Cervical Plate System, Substantially Equivalent on 2023-03-14. Applicant: Double Medical Technology, Inc.. Device class: 2.

Clearance details

Applicant: Double Medical Technology, Inc.
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2022-12-14
Decision date: 2023-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiamen, 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
K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
K260570 — corra cervical plating system2026-04-22
K260697 — VyPlate Anterior Cervical Plate System2026-03-27

More clearances from Double Medical Technology, Inc.

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K252729 — Universal Spinal System2025-11-18
K242348 — Locking Screw,CoCrMo2024-12-04
K233078 — Posterior Cervical Spine System2023-11-22
K221150 — Advanced Bone Plate2023-01-25
K221088 — Anatomic Bone Plate2023-01-18

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.