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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K120715
Device Name ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT
Applicant
Zimmer GmbH
P.O. Box 708
Warsaw,  IN  46581
Applicant Contact STEPHEN H MCKELVEY
Correspondent
Zimmer GmbH
P.O. Box 708
Warsaw,  IN  46581
Correspondent Contact STEPHEN H MCKELVEY
Regulation Number888.3020
Classification Product Code
HSB  
Date Received03/08/2012
Decision Date 08/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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