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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 K252567
Device Name AltiVate Reverse® ADLC Glenosphere
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  
Subsequent Product Code
KWS  
Date Received08/14/2025
Decision Date 01/15/2026
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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