FlexWing Anterior Cervical Plate System— 510(k) K231251

Name: FDA 510(k) clearance K231251
Creator: U.S. Food and Drug Administration
Published: 2024-07-24

Substantially Equivalent

Jeil Medical Corporation

FDA 510(k) clearance K231251 for FlexWing Anterior Cervical Plate System, Substantially Equivalent on 2024-07-24. Applicant: Jeil Medical Corporation. Device class: 2.

Clearance details

Applicant: Jeil Medical Corporation
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2023-05-01
Decision date: 2024-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

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

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K243973 — FIX-L PEEK PLIF and T-PLIF System2025-06-12
K242751 — ARIX Pectus Bar System2025-05-30

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.