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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 K152047
Device Name INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
Applicant
Ascension Orthopedics
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Applicant Contact WILLIAM GARZON
Correspondent
Ascension Orthopedics
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Correspondent Contact WILLIAM GARZON
Regulation Number888.3660
Classification Product Code
KWS  
Date Received07/23/2015
Decision Date 12/23/2015
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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