DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031

Intervertebral Fusion Device With Bone Graft, Lumbar

SPINEFRONTIER, INC.

The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Dorado Wide Intervertebral Body Cage, Models: Im2010-im2031.

Pre-market Notification Details

Device IDK091638
510k NumberK091638
Device Name:DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SPINEFRONTIER, INC. 500 CUMMINGS CENTER, STE. 3500 Beverly,  MA  01915
ContactJohn Sullivan
CorrespondentJohn Sullivan
SPINEFRONTIER, INC. 500 CUMMINGS CENTER, STE. 3500 Beverly,  MA  01915
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-04
Decision Date2009-09-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00190361006152 K091638 000
00190361006145 K091638 000

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