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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 K043570
Device Name UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD
Applicant
Conformis, Inc.
323 Vintage Park Dr.
Suite C
Foster City,  CA  94404
Applicant Contact LYNDALL ERB
Correspondent
Conformis, Inc.
323 Vintage Park Dr.
Suite C
Foster City,  CA  94404
Correspondent Contact LYNDALL ERB
Regulation Number888.3520
Classification Product Code
HSX  
Date Received12/27/2004
Decision Date 03/14/2005
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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