PROTEX CT CERVICOTHORACIC 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 Protex Ct Cervicothoracic Spinal System.

Pre-market Notification Details

Device IDK081906
510k NumberK081906
Device Name:PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon,  PA  19403
ContactKelly J Baker
CorrespondentKelly J Baker
GLOBUS MEDICAL, INC. 2560 GENERAL ARMISTEAD AVE. VALLEY FORGE BUSINESS CENTER Audubon,  PA  19403
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-03
Decision Date2008-11-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00889095037562 K081906 000
00889095037104 K081906 000
00889095037111 K081906 000
00889095037128 K081906 000
00889095037197 K081906 000
00889095037203 K081906 000
00889095037210 K081906 000
00889095037227 K081906 000
00889095037234 K081906 000
00889095037494 K081906 000
00889095037098 K081906 000

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