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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(k) Number K152825
Device Name Catalyst CSR Shoulder System
Applicant
Catalyst Orthoscience, LLC
5867 Whisperwood Ct.
Naples,  FL  34110
Applicant Contact STEPHEN HERRINGTON
Correspondent
Catalyst Orthoscience, LLC
5867 Whisperwood Ct.
Naples,  FL  34110
Correspondent Contact STEPHEN HERRINGTON
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Code
HSD  
Date Received09/29/2015
Decision Date 05/11/2016
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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