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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 Ave.
Burlington,  MA  01803
Applicant Contact MICHAEL SHARP
Correspondent
Conformis, Inc.
2 Fourth Ave.
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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