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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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K140257
Device Name SIGNATURE PLANNER, SIGNATURE GUIDES
Applicant
Materialise NV
15 Technologielaan
Leuven,  BE 3001
Applicant Contact OLIVER CLEMENS
Correspondent
Materialise NV
15 Technologielaan
Leuven,  BE 3001
Correspondent Contact OLIVER CLEMENS
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Codes
JWH   MBV   OIY   OOG  
Date Received02/03/2014
Decision Date 04/02/2014
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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