ABTross ALIF Expandable Cage System

Intervertebral Fusion Device With Bone Graft, Lumbar

Aegis Spine, Inc.

The following data is part of a premarket notification filed by Aegis Spine, Inc. with the FDA for Abtross Alif Expandable Cage System.

Pre-market Notification Details

Device IDK221719
510k NumberK221719
Device Name:ABTross ALIF Expandable Cage System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Aegis Spine, Inc. 9781 S. Meridian Blvd, Ste 300 Englewood,  CO  80112
ContactKiHyang Kim
CorrespondentKiHyang Kim
Aegis Spine, Inc. 9781 S. Meridian Blvd, Ste 300 Englewood,  CO  80112
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-13
Decision Date2022-11-03

NIH GUDID Devices

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