EPICAGE INTERBODY FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

R TREE INNOVATIONS

The following data is part of a premarket notification filed by R Tree Innovations with the FDA for Epicage Interbody Fusion Device.

Pre-market Notification Details

Device IDK092901
510k NumberK092901
Device Name:EPICAGE INTERBODY FUSION DEVICE
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant R TREE INNOVATIONS 13540 GUILD AVENUE Apple Valley,  MN  55124
ContactRichard Jansen
CorrespondentRichard Jansen
R TREE INNOVATIONS 13540 GUILD AVENUE Apple Valley,  MN  55124
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-21
Decision Date2010-04-28
Summary:summary

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