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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 K190588
Device Name Integra TITAN Reverse Shoulder System
Applicant
Integra LifeSciences Corporation
11101 Metric Blvd
Austin,  TX  78758
Applicant Contact Blesson Abraham
Correspondent
Integra LifeSciences Corporation
11101 Metric Blvd
Austin,  TX  78758
Correspondent Contact Blesson Abraham
Regulation Number888.3660
Classification Product Code
PHX  
Date Received03/07/2019
Decision Date 12/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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