FDA.report

510(k) K231251

Device
FlexWing Anterior Cervical Plate System
Applicant
Jeil Medical Corporation
510(k) number
K231251
Product code
KWQ
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-24
Date received
2023-05-01
Regulation
888.3060
Classification name
Appliance, Fixation, Spinal Intervertebral Body
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Sejin Ryu
Address
702,703,704,705,706,804,805,807,812,815-Ho, 55, Digital-Ro34-Gil, Guro-Gu Seoul KR 08378 08378

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
08800089448364FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089400676FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448227FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448234FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448241FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448258FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448265FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448272FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448289FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448296FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448302FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448319FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448326FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448333FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448340FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448357FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448562Surgical InstrumentJeil Medical Corporation2024-07-30
08800089448371FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448388FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448395FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448401FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448418FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448425FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448432FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448449FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448456FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448463FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448470FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448487FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30
08800089448494FlexWing Anterior Cervical Plate SystemJeil Medical Corporation2024-07-30

Other 510(k) Records For Product Code KWQ

510(k)DeviceApplicantDecision date
K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.2026-05-14
K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.2026-05-06
K260570corra™ cervical plating systemCarlsmed, Inc.2026-04-22
K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC2026-03-27
K260015ANTERIS Thoracolumbar Plate SystemSpineCraft2026-03-04
K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.2026-03-03
K254182AsterOsteonic Co., Ltd.2026-02-26
K253201Lumbar Spine Truss System - Plating Solution (LSTS-PS)4Web, Inc.2026-02-12
K252611aprevo® cervical plating systemCarlsmed, Inc.2025-12-22
K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.2025-08-28
K251436Resolve Anterior Cervical Plate SystemPioneer Surgical Technology, Inc.2025-07-11
K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.2025-05-23
K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.2025-05-20
K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)2025-04-10
K243904Elegance® Anterior Cervical plateClariance2025-01-14