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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 K203100
Device Name Arthrex Eclipse Titanium Humeral Head
Applicant
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108 -1945
Applicant Contact David L Rogers
Correspondent
Arthrex, Inc.
1370 Creekside Blvd.
Naples,  FL  34108 -1945
Correspondent Contact David L Rogers
Regulation Number888.3660
Classification Product Code
PKC  
Subsequent Product Code
QHQ  
Date Received10/14/2020
Decision Date 11/20/2020
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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