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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 K221337
Device Name Materialise TKA Guide System
Applicant
Materialise NV
Technologielaan 15
Leuven,  BE 3001
Applicant Contact Jenny Jones
Correspondent
Materialise NV
Technologielaan 15
Leuven,  BE 3001
Correspondent Contact Jenny Jones
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OIY   OOG  
Date Received05/09/2022
Decision Date 07/05/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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