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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Alterable
510(k) Number K261058
Device Name CraniUS Plate
Applicant
CraniUS, LLC
1700 Union Ave., Suite A1
Baltimore,  MD  21211
Applicant Contact Natalie Wisniewski
Correspondent
CraniUS, LLC
1700 Union Ave., Suite A1
Baltimore,  MD  21211
Correspondent Contact Oxana Pantchenko
Regulation Number882.5320
Classification Product Code
GWO  
Date Received03/31/2026
Decision Date 07/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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