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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
Recalls CDRH Recalls
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