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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(k) Number K123814
Device Name HUMELOCK II CEMENTED SHOULDER SYSTEM
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 JEAN-JACQUES MARTIN
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Code
HSD  
Date Received12/12/2012
Decision Date 08/13/2013
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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