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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
Recalls CDRH Recalls
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