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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, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K202207
Device Name Materialise PKA Guide System
Applicant
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Applicant Contact Veerle Vanderheyden
Correspondent
Materialise N.V
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact Veerle Vanderheyden
Regulation Number888.3520
Classification Product Code
HSX  
Subsequent Product Code
OOG  
Date Received08/06/2020
Decision Date 10/02/2020
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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