PROTEX CT

GUDID 00889095036473

3.5mm PROTEX CT Polyaxial Screw 28mm

GLOBUS MEDICAL, INC.

Trans-facet-screw internal spinal fixation system, sterile
Primary Device ID00889095036473
NIH Device Record Key8aa3762c-e268-41f6-b211-a572d339e656
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROTEX CT
Version Model Number115.328
Company DUNS139105691
Company NameGLOBUS MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(610)930-1800
Emailinfo@globusmedical.com

Device Dimensions

Length28 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100889095036473 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00889095036473]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2015-11-06

On-Brand Devices [PROTEX CT]

00889095037593Lateral Connector, Short
00889095037586Lateral Connector
00889095037579Tapered Rod, 3.7mm to 5.5mm, 500mm
00889095037562Tapered Rod, 3.2mm to 5.5mm, 350mm
00889095037555Tapered Rod, 3.7mm to 4.0mm, 350mm
00889095037548Tapered Rod, 3.7mm to 4.5mm, 350mm
00889095037531Tapered Rod, 3.7mm to 5.0mm, 350mm
00889095037524Tapered Rod, 3.7mm to 5.5mm, 350mm
00889095037517Tapered Rod, 3.7mm to 6.0mm, 350mm
00889095037500Tapered Rod, 3.7mm to 6.5mm, 350mm
00889095037494Tapered Rod, 3.2mm to 3.7mm, 240mm
00889095037487Parallel Connector, 3.7mm Rod to 4.0mm Rod
00889095037470Parallel Connector, 3.7mm Rod to 6.5mm Rod
00889095037463Parallel Connector, 3.7mm Rod to 6.0mm Rod
00889095037456Parallel Connector, 3.7mm Rod to 5.5mm Rod
00889095037449Parallel Connector, 3.7mm Rod to 5.0mm Rod
00889095037432Parallel Connector, 3.7mm Rod to 4.5mm Rod
00889095037425Parallel Connector, 3.7mm Rod to 3.7mm Rod
00889095037418Occipital Clamp, Double, Long
00889095037401Occipital Clamp, Double, Short
00889095037395Occipital Clamp, Triple, Long
00889095037388Occipital Clamp, Triple, Short
008890950373713.7mm Occipital Rod, 240mm, 130 deg
008890950373643.7mm Occipital Rod, 240mm, 115 deg
008890950373573.7mm Occipital Rod, 240mm, 100 deg
00889095037340Set Screw, M4.5 x 0.75
00889095037333Occipital Clamp, Single, Long
00889095037326Occipital Clamp, Single, Short
00889095037319Set Screw, M4.5x0.75, Round Tip, 2.5mm Hex
00889095037302Clamp for T-Connector, Right
00889095037296Clamp for T-Connector, Left
00889095037289Top-Loading T-Connector for 3.7mm Rod, 36-56, Straight
00889095037272Top-Loading T-Connector for 3.7mm Rod, 36-56mm, Curved
00889095037265Top-Loading T-Connector for 3.7mm Rod, 26-46mm, Straight
00889095037258Top-Loading T-Connector for 3.7mm Rod, 26-46mm, Curved
00889095037241Top-Loading T-Connector for 3.7mm Rod, 21-33mm, Straight
00889095037234Top-Loading T-Connector for 3.2mm Rod, 36-56, Straight
00889095037227Top-Loading T-Connector for 3.2mm Rod, 36-56mm, Curved
00889095037210Top-Loading T-Connector for 3.2mm Rod, 26-46mm, Straight
00889095037203Top-Loading T-Connector for 3.2mm Rod, 26-46mm, Curved
00889095037197Top-Loading T-Connector for 3.2mm Rod, 21-33mm, Straight
00889095037180Adjustable T-Connector for 3.7mm Rod, 41-56mm
00889095037173Adjustable T-Connector for 3.7mm Rod, 32-41mm
008890950371663.7mm Straight Rod, 40mm
008890950371593.7mm Straight Rod, 240mm
008890950371423.7mm Straight Rod, 120mm
008890950371353.7mm Straight Rod, 80mm
008890950371283.2mm Straight Ti Rod, 40mm
008890950371113.2mm Straight Ti Rod, 240mm
008890950371043.2mm Straight Ti Rod, 120mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.