EPICAGE INTERBODY FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Lumbar

ALPHATEC SPINE, INC.

The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Epicage Interbody Fusion Device.

Pre-market Notification Details

Device IDK130548
510k NumberK130548
Device Name:EPICAGE INTERBODY FUSION DEVICE
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad,  CA  92008
ContactNadine Smith
CorrespondentNadine Smith
ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad,  CA  92008
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-04
Decision Date2013-04-18
Summary:summary

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