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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 K161189
Device Name Integra TITAN Reverse Shoulder System
Applicant
Integra LifeSciences Corporation
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Applicant Contact William Garzon
Correspondent
Integra LifeSciences Corporation
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Correspondent Contact William Garzon
Regulation Number888.3660
Classification Product Code
PHX  
Date Received04/27/2016
Decision Date 08/25/2016
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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