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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Arthroplasty Implantation System
510(k) Number K212569
Device Name Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
Applicant
Materialise NV
Technologielaan 15
Leuven,  BE 3001
Applicant Contact Simona Beri
Correspondent
Materialise NV
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact Simona Beri
Regulation Number888.3660
Classification Product Code
QHE  
Subsequent Product Codes
KWS   PHX  
Date Received08/16/2021
Decision Date 01/12/2022
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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