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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K243904
Device Name Elegance® Anterior Cervical plate
Applicant
Clariance
18, Rue Robespierre
Beaurains,  FR 62217
Applicant Contact Quang Tran
Correspondent
Clariance
18, Rue Robespierre
Beaurains,  FR 62217
Correspondent Contact Quang Tran
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/19/2024
Decision Date 01/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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