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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 K252141
Device Name AltiVate Reverse® Glenoid
Applicant
Encore Medical L.P.
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact Patricia Kontoudis
Correspondent
Encore Medical L.P.
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact Patricia Kontoudis
Regulation Number888.3660
Classification Product Code
PHX  
Date Received07/08/2025
Decision Date 08/05/2025
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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