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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K111863
Device Name SIGNATURE PLANNER,SIGNATURE GUIDES
Applicant
Materialise N.V
15 Technologielaan
Leuven,  BE 3001
Applicant Contact ALAXANDRA RAZZHIVINA
Correspondent
Materialise N.V
15 Technologielaan
Leuven,  BE 3001
Correspondent Contact ALAXANDRA RAZZHIVINA
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KWY   KWZ   LPH   LZO   MAY  
MEH  
Date Received06/30/2011
Decision Date 06/15/2012
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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