FDA.reportPublic FDA data

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
No

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#

510(k) summary PDF

Other 510(k) Records For Product Code KWQ#

510(k), Device, Applicant table
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K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.2026-05-14
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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