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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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