OSTEOPORE PCL SCAFFOLD

Methyl Methacrylate For Cranioplasty

OSTEOPORE, INC.

The following data is part of a premarket notification filed by Osteopore, Inc. with the FDA for Osteopore Pcl Scaffold.

Pre-market Notification Details

Device IDK051093
510k NumberK051093
Device Name:OSTEOPORE PCL SCAFFOLD
ClassificationMethyl Methacrylate For Cranioplasty
Applicant OSTEOPORE, INC. 958 KRISTIN RIDGE WAY Milpitas,  CA  95035
ContactAlexander Yeo
CorrespondentAlexander Yeo
OSTEOPORE, INC. 958 KRISTIN RIDGE WAY Milpitas,  CA  95035
Product CodeGXP  
CFR Regulation Number882.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-04-28
Decision Date2006-03-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08885013200126 K051093 000
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08885013201840 K051093 000
08885013201390 K051093 000
08885013201383 K051093 000
08885013201376 K051093 000
08885013201307 K051093 000

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