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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 K965098
Device Name INTRAMEDULLARY NAIL SYSTEM
Applicant
ZIMMER, INC.
P.O. BOX 708
warsaw,  IN  46581 -0708
Applicant Contact karen cain
Correspondent
ZIMMER, INC.
P.O. BOX 708
warsaw,  IN  46581 -0708
Correspondent Contact karen cain
Regulation Number888.3020
Classification Product Code
HSB  
Date Received12/20/1996
Decision Date 02/28/1997
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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