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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 K233481
Device Name AltiVate Reverse® Glenoid
Applicant
Encore Medical, L.P.
9800 Metric Boulevard
Austin,  TX  78758
Applicant Contact Sherri Mellingen
Correspondent
Encore Medical, L.P.
9800 Metric Boulevard
Austin,  TX  78758
Correspondent Contact Sherri Mellingen
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
KWS  
Date Received10/26/2023
Decision Date 05/29/2024
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
Recalls CDRH Recalls
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