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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 K091566
Device Name ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
Applicant
ZIMMER GMBH
P.O. BOX 708
warsaw,  IN  46581 -0708
Applicant Contact daniel j williman
Correspondent
ZIMMER GMBH
P.O. BOX 708
warsaw,  IN  46581 -0708
Correspondent Contact daniel j williman
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/28/2009
Decision Date 10/28/2009
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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