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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, semi-constrained, cemented, metal/polymer
510(k) Number K110415
Device Name SIGNATURE PLANNER / SIGNATURE GUIDES
Applicant
MATERIALISE N.V.
15 TECHNOLOGIELAAN
LEUVEN,  BE 3001
Applicant Contact ALEXANDRA RAZZHIVANA
Correspondent
MATERIALISE N.V.
15 TECHNOLOGIELAAN
LEUVEN,  BE 3001
Correspondent Contact ALEXANDRA RAZZHIVANA
Regulation Number888.3530
Classification Product Code
HRY  
Subsequent Product Codes
JWH   MBH   OIY   OOG  
Date Received02/14/2011
Decision Date 05/16/2011
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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