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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 K231834
Device Name VSP PEEK Cranial Implant
Applicant
3D Systems, Inc.
5381 S. Alkire Cir.
Littleton,  CO  80127
Applicant Contact Ashley Dawson
Correspondent
3D Systems, Inc.
5381 S. Alkire Cir.
Littleton,  CO  80127
Correspondent Contact Ashley Dawson
Regulation Number882.5320
Classification Product Code
GWO  
Date Received06/22/2023
Decision Date 04/04/2024
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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