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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, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K063432
Device Name CONFORMIS METAL BACKED TIBIAL COMPONENT(MBT)
Applicant
Conformis, Inc.
323-C Vintage Park Dr.
Foster City,  CA  94404
Applicant Contact MICHAEL SHARP
Correspondent
Conformis, Inc.
323-C Vintage Park Dr.
Foster City,  CA  94404
Correspondent Contact MICHAEL SHARP
Regulation Number888.3520
Classification Product Code
HSX  
Date Received11/13/2006
Decision Date 03/16/2007
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
Recalls CDRH Recalls
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