IdentiTi Cervical Standalone Interbody System

Intervertebral Fusion Device With Integrated Fixation, Cervical

Alphatec Spine, Inc.

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

Pre-market Notification Details

Device IDK202812
510k NumberK202812
Device Name:IdentiTi Cervical Standalone Interbody System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant Alphatec Spine, Inc. 5818 El Camino Real Carlsbad,  CA  92008
ContactRuby Zheng
CorrespondentRuby Zheng
Alphatec Spine, Inc. 5818 El Camino Real Carlsbad,  CA  92008
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-24
Decision Date2020-12-18

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