FDA 510(k) Application Details - K120715

Device Classification Name Rod, Fixation, Intramedullary And Accessories

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510(K) Number K120715
Device Name Rod, Fixation, Intramedullary And Accessories
Applicant ZIMMER GMBH
P.O. BOX 708
WARSAW, IN 46581-0708 US
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Contact STEPHEN H MCKELVEY
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Regulation Number 888.3020

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Classification Product Code HSB
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Date Received 03/08/2012
Decision Date 08/10/2012
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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