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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name shoulder prosthesis, reverse configuration
510(k) Number K234105
Device Name Catalyst F1x Shoulder System
Applicant
Catalyst OrthoScience, Inc.
14710 Tamiami Trail, North Ste. 102
Naples,  FL  34110
Applicant Contact Dale Davison
Correspondent
Catalyst OrthoScience, Inc.
14710 Tamiami Trail, North Ste. 102
Naples,  FL  34110
Correspondent Contact Dale Davison
Regulation Number888.3660
Classification Product Code
PHX  
Date Received12/26/2023
Decision Date 04/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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