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FDA 510(k)

Elegance® Anterior Cervical plate

K-Number: K243904 · 2025-01-14

ApplicantClariance
Decision Date2025-01-14
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Elegance® Anterior Cervical plate is the device name listed in this FDA 510(k) record. The listed applicant is Clariance. It received FDA 510(k) clearance on 2025-01-14 under 510(k) number K243904. 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 Elegance® Anterior Cervical plate?

Elegance® Anterior Cervical plate is a medical device that received FDA 510(k) clearance on 2025-01-14. The listed applicant is Clariance. The 510(k) number is K243904.

When did Elegance® Anterior Cervical plate receive FDA 510(k) clearance?

Elegance® Anterior Cervical plate received FDA 510(k) clearance on 2025-01-14, under 510(k) number K243904.

Who is the listed applicant for Elegance® Anterior Cervical plate?

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

What is the FDA product code for Elegance® Anterior Cervical plate?

The FDA product code for Elegance® Anterior Cervical plate is KWQ.

Related Clinical Trials

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Other records listing Clariance as applicant

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.

K243670Idys® LIFK241863Erisma® Lp Spinal Fixation System; Erisma® LP MISK240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemK240715Idys® C ZP 3DTiK220182Aggeris™-CK212562Idys-C ZP 3DTi

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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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