EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE

Filler, Bone Void, Calcium Compound

ETEX CORP.

The following data is part of a premarket notification filed by Etex Corp. with the FDA for Equivabone Osteoinductive Bone Graft Substitute.

Pre-market Notification Details

Device IDK090855
510k NumberK090855
Device Name:EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE
ClassificationFiller, Bone Void, Calcium Compound
Applicant ETEX CORP. 38 SIDNEY ST. Cambridge,  MA  02139
ContactChristopher Klaczyk
CorrespondentChristopher Klaczyk
ETEX CORP. 38 SIDNEY ST. Cambridge,  MA  02139
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-30
Decision Date2009-09-18
Summary:summary

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