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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K162719
Device Name iTotal® Hip Replacement System
Applicant
ConforMIS, Inc.
28 Crosby Drive
Bedford,  MA  01730
Applicant Contact Amita Shah
Correspondent
ConforMIS, Inc.
600 Technology Park Drive
Billerica,  MA  01821
Correspondent Contact Emmanuel Nyakako
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
LZO   MEH   OQG  
Date Received09/29/2016
Decision Date 06/14/2017
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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