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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 K182500
Device Name Catalyst CSR Press-Fit Humeral Components
Applicant
Catalyst Orthoscience, Inc.
14710 Tamiami Trail N.
Naples,  FL  34110
Applicant Contact Dale Davison
Correspondent
Catalyst Orthoscience, Inc.
14710 Tamiami Trail N.
Naples,  FL  34110
Correspondent Contact Dale Davison
Regulation Number888.3650
Classification Product Code
KWT  
Subsequent Product Code
HSD  
Date Received09/12/2018
Decision Date 01/11/2019
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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