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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K190286
Device Name Materialise Glenoid Positioning System
Applicant
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Applicant Contact Mieke Janssen
Correspondent
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact Mieke Janssen
Regulation Number888.3660
Classification Product Code
KWS  
Date Received02/11/2019
Decision Date 07/08/2019
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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