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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
510(k) Number K213615
Device Name Shoulder Innovations Total Shoulder System
Applicant
Shoulder Innovations, Inc.
13827 Port Sheldon St.
Holland,  MI  49424
Applicant Contact Don Running
Correspondent
Shoulder Innovations, Inc.
13827 Port Sheldon St.
Holland,  MI  49424
Correspondent Contact Don Running
Regulation Number888.3660
Classification Product Code
PKC  
Date Received11/15/2021
Decision Date 03/11/2022
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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