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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K113718
Device Name NCB STRAIGHT NARROW SHAFT PLATES
Applicant
ZIMMER GMBH
PO BOX 708
warsaw,  IN  46581
Applicant Contact stephen h mckelvey
Correspondent
ZIMMER GMBH
PO BOX 708
warsaw,  IN  46581
Correspondent Contact stephen h mckelvey
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received12/19/2011
Decision Date 01/27/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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