ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM

Appliance, Fixation, Spinal Interlaminal

GLOBUS MEDICAL INC.

The following data is part of a premarket notification filed by Globus Medical Inc. with the FDA for Ellipse Occipito-cervico-thoracic Spinal System.

Pre-market Notification Details

Device IDK110963
510k NumberK110963
Device Name:ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon,  PA  19403
ContactKelly J Baker, Ph.d
CorrespondentKelly J Baker, Ph.d
GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. Audubon,  PA  19403
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-06
Decision Date2011-05-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00849044036404 K110963 000
00849044036268 K110963 000
00849044036275 K110963 000
00849044036282 K110963 000
00849044036299 K110963 000
00849044036305 K110963 000
00849044036312 K110963 000
00849044036329 K110963 000
00849044036336 K110963 000
00849044036343 K110963 000
00849044036350 K110963 000
00849044036367 K110963 000
00849044036374 K110963 000
00849044036381 K110963 000
00849044036398 K110963 000
00849044036251 K110963 000

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