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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 K173717
Device Name Integra TITAN Reverse Shoulder System
Applicant
Integra LifeSciences Corporation
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Applicant Contact Kathleen McGuire
Correspondent
Integra LifeSciences Corporation
8700 Cameron Rd., Suite 100
Austin,  TX  78754
Correspondent Contact Blesson Abraham
Regulation Number888.3660
Classification Product Code
PHX  
Date Received12/05/2017
Decision Date 06/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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