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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 K043270
Device Name SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES
Applicant
Zimmer GmbH
P.O. Box 708
Warsaw,  IN  46581 -0708
Applicant Contact LAURA D WILLIAMS
Correspondent
Zimmer GmbH
P.O. Box 708
Warsaw,  IN  46581 -0708
Correspondent Contact LAURA D WILLIAMS
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/26/2004
Decision Date 01/31/2005
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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