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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Prosthesis, Reverse Configuration
510(k) Number K163669
Device Name Humeris Shoulder
Applicant
Fx Solutions
1663 Rue De Majornas
Viriat,  FR 01440
Applicant Contact Jean-Jacques Martin
Correspondent
Fx Solutions
1663 Rue De Majornas
Viriat,  FR 01440
Correspondent Contact Ratsamy Thevenin
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWT  
Date Received12/27/2016
Decision Date 05/17/2017
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
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