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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 K212237
Device Name 3D-Cut
Applicant
3D-Side S.A.
Rue André Dumont 5
Mont-Saint-Guibert,  BE 1435
Applicant Contact Laurent Paul
Correspondent
Orthogrow NV
Davincilaan 1
Zaventem,  BE 1930
Correspondent Contact Niels Festjens
Regulation Number888.3030
Classification Product Code
PBF  
Subsequent Product Codes
HRS   HWC  
Date Received07/19/2021
Decision Date 11/29/2021
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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