ATEC Universal Spacer System

Intervertebral Fusion Device With Bone Graft, Thoracic

Alphatec Spine, Inc

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

Pre-market Notification Details

Device IDK180480
510k NumberK180480
Device Name:ATEC Universal Spacer System
ClassificationIntervertebral Fusion Device With Bone Graft, Thoracic
Applicant Alphatec Spine, Inc 5818 El Camino Real Carlsbad,  CA  92008
ContactJeremy Markovich
CorrespondentJeremy Markovich
Alphatec Spine, Inc 5818 El Camino Real Carlsbad,  CA  92008
Product CodePHM  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-23
Decision Date2018-05-31
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.