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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 a medical device manufactured by Jeil Medical Corporation. It received FDA 510(k) clearance on 2024-07-24 under approval 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. It is manufactured by Jeil Medical Corporation. The 510(k) number is K231251.

When was FlexWing Anterior Cervical Plate System approved by the FDA?

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

What company makes FlexWing Anterior Cervical Plate System?

FlexWing Anterior Cervical Plate System is manufactured by Jeil Medical Corporation.

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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Related Devices (Code: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, Inc.

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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