FDA 510(k) Application Details - K120121

Device Classification Name

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510(K) Number K120121
Device Name COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE
Applicant BIOMET, INC.
P.O. BOX 587
WARSAW, IN 46581-0587 US
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Contact PATRICIA BERES
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Regulation Number

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Classification Product Code PHX
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Date Received 01/17/2012
Decision Date 02/16/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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