ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE 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 Bone Graft Substitute And E-z-fil And Shape Bone Graft Substitute.

Pre-market Notification Details

Device IDK081979
510k NumberK081979
Device Name:ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE 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 Received2008-07-11
Decision Date2008-11-06
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.