ATEC Cervical Spacer System

Intervertebral Fusion Device With Bone Graft, Cervical

Alphatec Spine, Inc.

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

Pre-market Notification Details

Device IDK181435
510k NumberK181435
Device Name:ATEC Cervical Spacer System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Alphatec Spine, Inc. 5818 El Camino Real Carlsbad,  CA  92008
ContactCynthia Adams
CorrespondentCynthia Adams
Alphatec Spine, Inc. 5818 El Camino Real Carlsbad,  CA  92008
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-01
Decision Date2018-08-21
Summary:summary

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