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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 K222936
Device Name Humeris® 135 Shoulder System
Applicant
FX Shoulder USA, Inc.
13465 Midway Road
Suite 101
Dallas,  TX  75244
Applicant Contact Cory Trier
Correspondent
FX Shoulder USA, Inc.
13465 Midway Road
Suite 101
Dallas,  TX  75244
Correspondent Contact Cory Trier
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWT  
Date Received09/26/2022
Decision Date 11/07/2022
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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