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 IDK193106
510k NumberK193106
Device Name:SpineFrontier Lumbar Interbody Fusion Device System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant SpineFrontier, Inc. 350 Main Street Malden,  MA  02148
ContactVito Lore
CorrespondentOmkar Joglekar
SpineFrontier, Inc. 350 Main St, 2nd Floor Malden,  MA  02148
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-08
Decision Date2020-06-19

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