VIP

GUDID 00849044085389

VIP Cervical Plate 2-Level, 28mm

GLOBUS MEDICAL, INC.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00849044085389
NIH Device Record Key9362399d-3977-4f08-a9e4-60ad1ee9f9d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIP
Version Model Number171.228
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

Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter
Length28 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100849044085389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00849044085389]

Moist Heat or Steam Sterilization


[00849044085389]

Moist Heat or Steam Sterilization


[00849044085389]

Moist Heat or Steam Sterilization


[00849044085389]

Moist Heat or Steam Sterilization


[00849044085389]

Moist Heat or Steam Sterilization


[00849044085389]

Moist Heat or Steam Sterilization


[00849044085389]

Moist Heat or Steam Sterilization


[00849044085389]

Moist Heat or Steam Sterilization


[00849044085389]

Moist Heat or Steam Sterilization


[00849044085389]

Moist Heat or Steam Sterilization


[00849044085389]

Moist Heat or Steam Sterilization


[00849044085389]

Moist Heat or Steam Sterilization


[00849044085389]

Moist Heat or Steam Sterilization


[00849044085389]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-01

On-Brand Devices [VIP]

00849044085921VIP 5.1mm Fixed Angle Screw, Self-Tapping, 26mm
00849044085914VIP 5.1mm Fixed Angle Screw, Self-Tapping, 24mm
00849044085907VIP 5.1mm Fixed Angle Screw, Self-Tapping, 22mm
00849044085891VIP 5.1mm Fixed Angle Screw, Self-Tapping, 20mm
00849044085884VIP 5.1mm Fixed Angle Screw, Self-Tapping, 18mm
00849044085877VIP 5.1mm Fixed Angle Screw, Self-Tapping, 16mm
00849044085860VIP 5.1mm Fixed Angle Screw, Self-Tapping, 14mm
00849044085853VIP 5.1mm Fixed Angle Screw, Self-Tapping, 12mm
00849044085846VIP 5.1mm Fixed Angle Screw, Self-Drilling, 16mm
00849044085839VIP 5.1mm Fixed Angle Screw, Self-Drilling, 14mm
00849044085822VIP 5.1mm Fixed Angle Screw, Self-Drilling, 12mm
00849044085815VIP 4.6mm Fixed Angle Screw, Self-Tapping, 26mm
00849044085808VIP 4.6mm Fixed Angle Screw, Self-Tapping, 24mm
00849044085792VIP 4.6mm Fixed Angle Screw, Self-Tapping, 22mm
00849044085785VIP 4.6mm Fixed Angle Screw, Self-Tapping, 20mm
00849044085778VIP 4.6mm Fixed Angle Screw, Self-Tapping, 18mm
00849044085761VIP 4.6mm Fixed Angle Screw, Self-Tapping, 16mm
00849044085754VIP 4.6mm Fixed Angle Screw, Self-Tapping, 14mm
00849044085747VIP 4.6mm Fixed Angle Screw, Self-Tapping, 12mm
00849044085730VIP 4.6mm Fixed Angle Screw, Self-Drilling, 16mm
00849044085723VIP 4.6mm Fixed Angle Screw, Self-Drilling, 14mm
00849044085716VIP 4.6mm Fixed Angle Screw, Self-Drilling, 12mm
00849044085709VIP 5.1mm Variable Angle Screw, Self-Tapping, 26mm
00849044085693VIP 5.1mm Variable Angle Screw, Self-Tapping, 24mm
00849044085686VIP 5.1mm Variable Angle Screw, Self-Tapping, 22mm
00849044085679VIP 5.1mm Variable Angle Screw, Self-Tapping, 20mm
00849044085662VIP 5.1mm Variable Angle Screw, Self-Tapping, 18mm
00849044085655VIP 5.1mm Variable Angle Screw, Self-Tapping, 16mm
00849044085648VIP 5.1mm Variable Angle Screw, Self-Tapping, 14mm
00849044085631VIP 5.1mm Variable Angle Screw, Self-Tapping, 12mm
00849044085624VIP 5.1mm Variable Angle Screw, Self-Drilling, 16mm
00849044085617VIP 5.1mm Variable Angle Screw, Self-Drilling, 14mm
00849044085600VIP 5.1mm Variable Angle Screw, Self-Drilling, 12mm
00849044085594VIP 4.6mm Variable Angle Screw, Self-Tapping, 26mm
00849044085587VIP 4.6mm Variable Angle Screw, Self-Tapping, 24mm
00849044085570VIP 4.6mm Variable Angle Screw, Self-Tapping, 22mm
00849044085563VIP 4.6mm Variable Angle Screw, Self-Tapping, 20mm
00849044085556VIP 4.6mm Variable Angle Screw, Self-Tapping, 18mm
00849044085549VIP 4.6mm Variable Angle Screw, Self-Tapping, 16mm
00849044085532VIP 4.6mm Variable Angle Screw, Self-Tapping, 14mm
00849044085525VIP 4.6mm Variable Angle Screw, Self-Tapping, 12mm
00849044085518VIP Anterior Cervical Plate 2-Level, 32mm, Extra Lordotic
00849044085501VIP Anterior Cervical Plate 2-Level, 30mm, Extra Lordotic
00849044085495VIP Anterior Cervical Plate 2-Level, 28mm, Extra Lordotic
00849044085488VIP Anterior Cervical Plate 2-Level, 26mm, Extra Lordotic
00849044085471VIP Cervical Plate 2-Level, 46mm
00849044085464VIP Cervical Plate 2-Level, 44mm
00849044085457VIP Cervical Plate 2-Level, 42mm
00849044085440VIP Cervical Plate 2-Level, 40mm
00849044085433VIP Cervical Plate 2-Level, 38mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.