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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 K172767
Device Name Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid
Applicant
Zimmer, Inc.
345 E. Main St.
Warsaw,  IN  46580
Applicant Contact Ehab Esmail
Correspondent
Zimmer, Inc.
56 E Bell Dr.
Warsaw,  IN  46581
Correspondent Contact Andrew Steward
Regulation Number888.3660
Classification Product Code
PHX  
Subsequent Product Codes
HSD   KWS   KWT  
Date Received09/13/2017
Decision Date 11/30/2017
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
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