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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K150928
Device Name Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides
Applicant
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Applicant Contact Laurel Berzanskis
Correspondent
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact Laurel Berzanskis
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OIY   OOG  
Date Received04/06/2015
Decision Date 08/10/2015
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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