SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT

Bone Cement

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Smartmix Cemvac Pre-filled With Smartset Hv Bone Cement.

Pre-market Notification Details

Device IDK053445
510k NumberK053445
Device Name:SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT
ClassificationBone Cement
Applicant DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
ContactNatalie S Heck
CorrespondentNatalie S Heck
DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw,  IN  46581 -0988
Product CodeLOD  
Subsequent Product CodeJDZ
Subsequent Product CodeKIH
Subsequent Product CodeMBB
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-12
Decision Date2006-01-06
Summary:summary

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