BONE SOURCE HAC RAPID SETTING CEMENT

Methyl Methacrylate For Cranioplasty

STRYKER INSTRUMENTS

The following data is part of a premarket notification filed by Stryker Instruments with the FDA for Bone Source Hac Rapid Setting Cement.

Pre-market Notification Details

Device IDK043334
510k NumberK043334
Device Name:BONE SOURCE HAC RAPID SETTING CEMENT
ClassificationMethyl Methacrylate For Cranioplasty
Applicant STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo,  MI  49001
ContactWade T Rutkoskie
CorrespondentWade T Rutkoskie
STRYKER INSTRUMENTS 4100 EAST MILHAM AVE. Kalamazoo,  MI  49001
Product CodeGXP  
CFR Regulation Number882.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-03
Decision Date2005-02-09
Summary:summary

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