ACCULIF CAGE

Intervertebral Fusion Device With Bone Graft, Lumbar

COALIGN INNOVATIONS, INC.

The following data is part of a premarket notification filed by Coalign Innovations, Inc. with the FDA for Acculif Cage.

Pre-market Notification Details

Device IDK110270
510k NumberK110270
Device Name:ACCULIF CAGE
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant COALIGN INNOVATIONS, INC. 1331 H STREET NW 12TH FLOOR Washington,  DC  20005
ContactJustin Eggleton
CorrespondentJustin Eggleton
COALIGN INNOVATIONS, INC. 1331 H STREET NW 12TH FLOOR Washington,  DC  20005
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-31
Decision Date2011-04-07
Summary:summary

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