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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopaedic Surgical Planning And Instrument Guides
510(k) Number K250711
Device Name VSP Orthopedics System
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 Number888.3030
Classification Product Code
PBF  
Date Received03/10/2025
Decision Date 12/05/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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