SpineFrontier Lumbar Interbody Fusion Device System

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 Spinefrontier Lumbar Interbody Fusion Device System.

Pre-market Notification Details

Device IDK142504
510k NumberK142504
Device Name:SpineFrontier Lumbar Interbody Fusion Device System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SpineFrontier, Inc. 500 Cummings Center, Suite 3500 Beverly,  MA  01915
ContactManthan Damani
CorrespondentMeredith May
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-05
Decision Date2015-05-13
Summary:summary

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