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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 K072368
Device Name CONFORMIS METAL BACKED TIBIAL COMPONENT
Applicant
CONFORMIS, INC.
2 FOURTH AVENUE
BURLINGTON,  MA  01803
Applicant Contact MICHAEL SHARP
Correspondent
CONFORMIS, INC.
2 FOURTH AVENUE
BURLINGTON,  MA  01803
Correspondent Contact MICHAEL SHARP
Regulation Number888.3520
Classification Product Code
HSX  
Date Received08/23/2007
Decision Date 09/20/2007
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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