Atlas Spine Expandable Cervical Standalone Interbody System

Intervertebral Fusion Device With Integrated Fixation, Cervical

Atlas Spine, Inc.

The following data is part of a premarket notification filed by Atlas Spine, Inc. with the FDA for Atlas Spine Expandable Cervical Standalone Interbody System.

Pre-market Notification Details

Device IDK192570
510k NumberK192570
Device Name:Atlas Spine Expandable Cervical Standalone Interbody System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant Atlas Spine, Inc. 1555 Jupiter Park Drive, Suite 1 Jupiter,  FL  33458
ContactThomas Smith
CorrespondentThomas Smith
Atlas Spine, Inc. 1555 Jupiter Park Drive, Suite 1 Jupiter,  FL  33458
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-18
Decision Date2020-02-28

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