SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES

Rod, Fixation, Intramedullary And Accessories

ZIMMER GMBH

The following data is part of a premarket notification filed by Zimmer Gmbh with the FDA for Sirus Intramedullary Nail-femoral And Tibial Nails, Models 02.02631, 02.02651, 02.02652 Series.

Pre-market Notification Details

Device IDK043270
510k NumberK043270
Device Name:SIRUS INTRAMEDULLARY NAIL-FEMORAL AND TIBIAL NAILS, MODELS 02.02631, 02.02651, 02.02652 SERIES
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant ZIMMER GMBH P.O. BOX 708 Warsaw,  IN  46581 -0708
ContactLaura D Williams
CorrespondentLaura D Williams
ZIMMER GMBH P.O. BOX 708 Warsaw,  IN  46581 -0708
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-26
Decision Date2005-01-31
Summary:summary

NIH GUDID Devices

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