IdentiTi ALIF Standalone Interbody System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Alphatec Spine Inc.

The following data is part of a premarket notification filed by Alphatec Spine Inc. with the FDA for Identiti Alif Standalone Interbody System.

Pre-market Notification Details

Device IDK203742
510k NumberK203742
Device Name:IdentiTi ALIF Standalone Interbody System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant Alphatec Spine Inc. 5818 El Camino Real Carlsbad,  CA  92008
ContactCynthia Dorne
CorrespondentCynthia Dorne
Alphatec Spine Inc. 5818 El Camino Real Carlsbad,  CA  92008
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-22
Decision Date2021-04-09

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