SIMPLEX X

Bone Cement

STRYKER CORP.

The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Simplex X.

Pre-market Notification Details

Device IDK032945
510k NumberK032945
Device Name:SIMPLEX X
ClassificationBone Cement
Applicant STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo,  MI  49001
ContactDannielle Wheeler
CorrespondentDannielle Wheeler
STRYKER CORP. 4100 E. MILHAM AVE. Kalamazoo,  MI  49001
Product CodeLOD  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-22
Decision Date2004-05-25
Summary:summary

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