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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 K193394
Device Name Humeral Cup Stability & Humeral Cup 135/145o Stability
Applicant
FX Shoulder USA, Inc.
13465 Midway Road, Suite 101
Dallas,  TX  75244
Applicant Contact Kathy Trier
Correspondent
FX Shoulder USA, Inc.
13465 Midway Road, Suite 101
Dallas,  TX  75244
Correspondent Contact Kathy Trier
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWT  
Date Received12/06/2019
Decision Date 04/29/2020
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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