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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 K210790
Device Name Lateralized and Augmented Baseplates
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 Code
HSD  
Date Received03/16/2021
Decision Date 08/25/2021
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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