Lucent 3D Spinal System

Intervertebral Fusion Device With Bone Graft, Lumbar

Spinal Elements, Inc.

The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Lucent 3d Spinal System.

Pre-market Notification Details

Device IDK203254
510k NumberK203254
Device Name:Lucent 3D Spinal System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Spinal Elements, Inc. 3115 Melrose Dr., Suite 200 Carlsbad,  CA  92010
ContactJulie Lamothe
CorrespondentJulie Lamothe
Spinal Elements, Inc. 3115 Melrose Dr., Suite 200 Carlsbad,  CA  92010
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-04
Decision Date2021-03-26

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