MODULIF-A Anterior Lumbar Interbody Fusion System

Intervertebral Fusion Device With Bone Graft, Lumbar

Spinal Stability, LLC

The following data is part of a premarket notification filed by Spinal Stability, Llc with the FDA for Modulif-a Anterior Lumbar Interbody Fusion System.

Pre-market Notification Details

Device IDK200958
510k NumberK200958
Device Name:MODULIF-A Anterior Lumbar Interbody Fusion System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Spinal Stability, LLC 104 Hensley Circle Austin,  TX  78738
ContactDavid Krueger
CorrespondentJ.d. Webb
The OrthoMedix Group, Inc 4313 W. 3800 S. West Haven,  UT  84401
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-10
Decision Date2020-08-28

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