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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 K231445
Device Name LINK Embrace Shoulder System - Reverse Configuration
Applicant
Waldemar Link GmbH & Co. KG
Barkhausenweg 10
Hamburg,  DE 22339
Applicant Contact Stefanie Fuchs
Correspondent
LinkBio Corp.
69 King St.
Dover,  NJ  07801
Correspondent Contact Mateusz Leszczak
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Code
PAO  
Date Received05/18/2023
Decision Date 11/16/2023
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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