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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
Applicant
MATERIALISE N.V.
TECHNOLOGIELAAN 15
LEUVEN,  BE 3001
Applicant Contact Alexandra Razzhivina
Correspondent
MATERIALISE N.V.
TECHNOLOGIELAAN 15
LEUVEN,  BE 3001
Correspondent 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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