ASSURE

GUDID 00849044000153

4.5mm Standard Screw, Self-Tapping, 8mm

GLOBUS MEDICAL, INC.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID00849044000153
NIH Device Record Keyc60dcacf-e7c7-4191-9e92-50b3a90602de
Commercial Distribution StatusIn Commercial Distribution
Brand NameASSURE
Version Model Number110.908
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
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com
Phone+1(610)930-1800
Emailinfo@globusmedical.com

Device Dimensions

Length8 Millimeter
Length8 Millimeter
Outer Diameter4.5 Millimeter
Length8 Millimeter
Outer Diameter4.5 Millimeter
Length8 Millimeter
Outer Diameter4.5 Millimeter
Length8 Millimeter
Outer Diameter4.5 Millimeter
Length8 Millimeter
Outer Diameter4.5 Millimeter
Length8 Millimeter
Outer Diameter4.5 Millimeter
Length8 Millimeter
Outer Diameter4.5 Millimeter
Length8 Millimeter
Outer Diameter4.5 Millimeter
Length8 Millimeter
Outer Diameter4.5 Millimeter
Length8 Millimeter
Outer Diameter4.5 Millimeter
Length8 Millimeter
Outer Diameter4.5 Millimeter
Length8 Millimeter
Outer Diameter4.5 Millimeter
Length8 Millimeter
Outer Diameter4.5 Millimeter
Length8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100849044000153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00849044000153]

Moist Heat or Steam Sterilization

[00849044000153]

Moist Heat or Steam Sterilization

[00849044000153]

Moist Heat or Steam Sterilization

[00849044000153]

Moist Heat or Steam Sterilization

[00849044000153]

Moist Heat or Steam Sterilization

[00849044000153]

Moist Heat or Steam Sterilization

[00849044000153]

Moist Heat or Steam Sterilization

[00849044000153]

Moist Heat or Steam Sterilization

[00849044000153]

Moist Heat or Steam Sterilization

[00849044000153]

Moist Heat or Steam Sterilization

[00849044000153]

Moist Heat or Steam Sterilization

[00849044000153]

Moist Heat or Steam Sterilization

[00849044000153]

Moist Heat or Steam Sterilization

[00849044000153]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-11-07

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00849044093131ASSURE Cervical Plate 3-Level, 57mm
00849044093124ASSURE Cervical Plate 3-Level, 54mm
00849044093117ASSURE Cervical Plate 3-Level, 51mm
00849044093100ASSURE Cervical Plate 3-Level, 48mm
00849044093094ASSURE Cervical Plate 3-Level, 45mm
00849044093087ASSURE Cervical Plate 2-Level, 46mm
00849044093070ASSURE Cervical Plate 2-Level, 44mm
00849044093063ASSURE Cervical Plate 2-Level, 42mm
00849044093056ASSURE Cervical Plate 2-Level, 40mm
00849044093049ASSURE Cervical Plate 2-Level, 38mm
00849044093032ASSURE Cervical Plate 2-Level, 36mm
00849044093025ASSURE Cervical Plate 2-Level, 34mm
00849044093018ASSURE Cervical Plate 2-Level, 32mm
00849044093001ASSURE Cervical Plate 2-Level, 30mm
00849044092998ASSURE Cervical Plate 2-Level, 28mm
00849044092981ASSURE Cervical Plate 2-Level, 26mm
00849044092974ASSURE Cervical Plate 1-Level, 26mm
00849044092967ASSURE Cervical Plate 1-Level, 24mm
00849044092950ASSURE Cervical Plate 1-Level, 22mm
00849044092943ASSURE Cervical Plate 1-Level, 20mm
00849044092936ASSURE Cervical Plate 1-Level, 18mm
00849044092929ASSURE Cervical Plate 1-Level, 16mm
00849044092912ASSURE Cervical Plate 1-Level, 14mm
00849044090673Set Screw for Rigid Screws
008490440906664.5mm Rigid Screw, Self-Tapping, 20mm
008490440906594.5mm Rigid Screw, Self-Tapping, 18mm
008490440906424.5mm Rigid Screw, Self-Tapping, 16mm
008490440906354.5mm Rigid Screw, Self-Tapping, 14mm
008490440906284.5mm Rigid Screw, Self-Tapping, 12mm
008490440906114.5mm Rigid Screw, Self-Drilling, 16mm
008490440906044.5mm Rigid Screw, Self-Drilling, 14mm
008490440905984.5mm Rigid Screw, Self-Drilling, 12mm
008490440905814.0mm Rigid Screw, Self-Tapping, 20mm
008490440905744.0mm Rigid Screw, Self-Tapping, 18mm
008490440905674.0mm Rigid Screw, Self-Tapping, 16mm
008490440905504.0mm Rigid Screw, Self-Tapping, 14mm
008490440905434.0mm Rigid Screw, Self-Tapping, 12mm
008490440905364.0mm Rigid Screw, Self-Tapping, 10mm
008490440905294.0mm Rigid Screw, Self-Drilling, 16mm
008490440905124.0mm Rigid Screw, Self-Drilling, 14mm
008490440905054.0mm Rigid Screw, Self-Drilling, 12mm
008490440904994.0mm Rigid Screw, Self-Drilling, 10mm
008490440904824.5mm Standard Screw, Self-Tapping, 20mm
008490440904754.5mm Standard Screw, Self-Tapping, 18mm
008490440904684.0mm Standard Screw, Self-Tapping, 20mm
008490440904514.0mm Standard Screw, Self-Tapping, 18mm

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ASSURE
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2022-06-08
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2020-11-12
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2020-10-06
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2020-07-01
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2020-05-10
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2020-03-17
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