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FDA 510(k)

FlexWing Anterior Cervical Plate System

K-Number: K231251 · 2024-07-24

ApplicantJeil Medical Corporation
Decision Date2024-07-24
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FlexWing Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Jeil Medical Corporation. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K231251. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlexWing Anterior Cervical Plate System?

FlexWing Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Jeil Medical Corporation. The 510(k) number is K231251.

When did FlexWing Anterior Cervical Plate System receive FDA 510(k) clearance?

FlexWing Anterior Cervical Plate System received FDA 510(k) clearance on 2024-07-24, under 510(k) number K231251.

Who is the listed applicant for FlexWing Anterior Cervical Plate System?

The FDA 510(k) record lists Jeil Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FlexWing Anterior Cervical Plate System?

The FDA product code for FlexWing Anterior Cervical Plate System is KWQ.

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Other records listing Jeil Medical Corporation as applicant

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Related Devices (Code: KWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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