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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 a medical device manufactured by Clariance. It received FDA 510(k) clearance on 2025-01-14 under approval 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. It is manufactured by Clariance. The 510(k) number is K243904.

When was Elegance® Anterior Cervical plate approved by the FDA?

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

What company makes Elegance® Anterior Cervical plate?

Elegance® Anterior Cervical plate is manufactured by Clariance.

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

NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT04214535 Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-Levels ACTIVE_NOT_RECRUITING

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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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