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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, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K130050
Device Name TITAN REVERSE SHOULDER SYSTEM
Applicant
Ascension Orthopedic
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Applicant Contact SUSAN WALTON
Correspondent
Ascension Orthopedic
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Correspondent Contact SUSAN WALTON
Regulation Number888.3660
Classification Product Code
KWS  
Subsequent Product Code
PHX  
Date Received01/09/2013
Decision Date 06/18/2013
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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