ACTIFUSE FLOW BONE GRAFT SUBSTITUTE

Filler, Bone Void, Calcium Compound

APATECH LTD.

The following data is part of a premarket notification filed by Apatech Ltd. with the FDA for Actifuse Flow Bone Graft Substitute.

Pre-market Notification Details

Device IDK082073
510k NumberK082073
Device Name:ACTIFUSE FLOW BONE GRAFT SUBSTITUTE
ClassificationFiller, Bone Void, Calcium Compound
Applicant APATECH LTD. 15058 ARMEL DRIVE Oregon City,  OR  97045
ContactCandace F Cederman
CorrespondentCandace F Cederman
APATECH LTD. 15058 ARMEL DRIVE Oregon City,  OR  97045
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-23
Decision Date2008-09-11
Summary:summary

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