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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 K102795
Device Name SIGNATURE PLANNER; SIGNATURE GUIDES
Original Applicant
MATERIALISE N.V.
technologielaan 15
leuven,  BE 3001
Original Contact alexandra razzhivina
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Codes
MBH   OIY   OOG  
Date Received09/27/2010
Decision Date 02/02/2011
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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