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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 K192206
Device Name 32mm Glenosphere and Humeral Cup
Applicant
Fx Shoulder USA, Inc.
13465 Midway Rd.
Suite 101
Dallas,  TX  75244
Applicant Contact Kathy Trier
Correspondent
Fx Shoulder USA, Inc.
13465 Midway Rd.
Suite 101
Dallas,  TX  75244
Correspondent Contact Kathy Trier
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWT  
Date Received08/14/2019
Decision Date 10/08/2019
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
Recalls CDRH Recalls
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