ATEC Alignment App

System, Image Processing, Radiological

Alphatec Spine, Inc.

The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Atec Alignment App.

Pre-market Notification Details

Device IDK211987
510k NumberK211987
Device Name:ATEC Alignment App
ClassificationSystem, Image Processing, Radiological
Applicant Alphatec Spine, Inc. 1950 Camina Vida Roble Carlsbad,  CA  92008
ContactDavid Gramse
CorrespondentDavid Gramse
Alphatec Spine, Inc. 1950 Camino Vida Roble Carlsbad,  CA  92008
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-28
Decision Date2021-10-29

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