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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 K181287
Device Name Catalyst CSR Shoulder System
Applicant
Catalyst OrthoScience, Inc.
14710 Tamiami Trail North, Suite 102
Naples,  FL  34110
Applicant Contact Dale Davison
Correspondent
Catalyst OrthoScience, Inc.
14710 Tamiami Trail North, Suite 102
Naples,  FL  34110
Correspondent Contact Dale Davison
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Code
HSD  
Date Received05/16/2018
Decision Date 07/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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