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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 K192198
Device Name Conformis Hip System
Applicant
Conformis, Inc.
600 Technology Park
Billerica,  MA  01821
Applicant Contact Paul Smolenski
Correspondent
Conformis, Inc.
600 Technology Park
Billerica,  MA  01821
Correspondent Contact Paul Smolenski
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
LZO   MEH   OQG  
Date Received08/13/2019
Decision Date 11/06/2019
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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