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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 K093513
Device Name IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
Applicant
CONFORMIS, INC.
2 FOURTH AVENUE
BURLINGTON,  MA  01803
Applicant Contact AMITA SHAH, RAC
Correspondent
CONFORMIS, INC.
2 FOURTH AVENUE
BURLINGTON,  MA  01803
Correspondent Contact AMITA SHAH, RAC
Regulation Number888.3560
Classification Product Code
NPJ  
Date Received11/13/2009
Decision Date 12/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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