ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE

Bone Grafting Material, Synthetic

APATECH LTD.

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

Pre-market Notification Details

Device IDK090850
510k NumberK090850
Device Name:ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
ClassificationBone Grafting Material, Synthetic
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 CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-03-30
Decision Date2009-07-30
Summary:summary

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