FDA 510(k) Application Details - K172767

Device Classification Name

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510(K) Number K172767
Device Name Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid
Applicant Zimmer, Inc.
345 East Main Street
Warsaw, IN 46580 US
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Contact Ehab Esmail
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Regulation Number

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Classification Product Code PHX
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Date Received 09/13/2017
Decision Date 11/30/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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