ALTERA SPACER

Intervertebral Fusion Device With Bone Graft, Lumbar

GLOBUS MEDICAL INC.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Altera Spacer.

Pre-market Notification Details

Device IDK140411
510k NumberK140411
Device Name:ALTERA SPACER
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon,  PA  19403
ContactChristina Kichula
CorrespondentChristina Kichula
GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon,  PA  19403
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-18
Decision Date2014-07-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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