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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 patellofemorotibial, partial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K053488
Device Name CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM
Applicant
CONFORMIS, INC.
323 VINTAGE PARK DR.
SUITE C
FOSTER CITY,  CA  94404
Applicant Contact PATRICK HESS
Correspondent
CONFORMIS, INC.
323 VINTAGE PARK DR.
SUITE C
FOSTER CITY,  CA  94404
Correspondent Contact PATRICK HESS
Regulation Number888.3560
Classification Product Code
NPJ  
Date Received12/15/2005
Decision Date 03/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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