ATEC Lateral Interbody System

Intervertebral Fusion Device With Bone Graft, Lumbar

Alphatec Spine, Inc.

The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Atec Lateral Interbody System.

Pre-market Notification Details

Device IDK202587
510k NumberK202587
Device Name:ATEC Lateral Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Alphatec Spine, Inc. 5818 El Camino Real Carlsbad,  CA  92008
ContactSandy Gill
CorrespondentSandy Gill
Alphatec Spine, Inc. 5818 El Camino Real Carlsbad,  CA  92008
Product CodeMAX  
Subsequent Product CodeOVD
Subsequent Product CodePHM
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-08
Decision Date2020-11-06

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