INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076

Intervertebral Fusion Device With Bone Graft, Lumbar

VERTEBRAL TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Vertebral Technologies, Inc. with the FDA for Interfuse Invertebral Body Fusion Device Model 9076.

Pre-market Notification Details

Device IDK093675
510k NumberK093675
Device Name:INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant VERTEBRAL TECHNOLOGIES, INC. 5909 Baker Road Suite 550 Minnetonka,  MN  55345
ContactSuresh Ghai
CorrespondentSuresh Ghai
VERTEBRAL TECHNOLOGIES, INC. 5909 Baker Road Suite 550 Minnetonka,  MN  55345
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-27
Decision Date2009-12-23
Summary:summary

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