Axis Spine Technologies ALIF

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Axis Spine Technologies Ltd

The following data is part of a premarket notification filed by Axis Spine Technologies Ltd with the FDA for Axis Spine Technologies Alif.

Pre-market Notification Details

Device IDK210590
510k NumberK210590
Device Name:Axis Spine Technologies ALIF
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant Axis Spine Technologies Ltd Suite 204, 54-56 Victoria Street, St. Albans,  GB Al1 3hz
ContactEdwin Lindsay
CorrespondentEdwin Lindsay
Axis Spine Technologies Ltd Suite 204, 54-56 Victoria Street, St. Albans,  GB Al1 3hz
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-01
Decision Date2021-09-29

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