CITADEL

GUDID 00849044037128

CITADEL 6.5mm Cannulated Screw, 51mm

GLOBUS MEDICAL, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00849044037128
• NIH Device Record Key: 7d74e9e5-84ad-4a5d-8780-6a0e6d565801
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CITADEL
• Version Model Number: 130.451
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com
• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Dimensions

• Length: 51 Millimeter
• Length: 51 Millimeter
• Length: 51 Millimeter
• Length: 51 Millimeter
• Length: 51 Millimeter
• Length: 51 Millimeter
• Length: 51 Millimeter
• Length: 51 Millimeter
• Length: 51 Millimeter
• Length: 51 Millimeter
• Length: 51 Millimeter
• Length: 51 Millimeter
• Length: 51 Millimeter
• Length: 51 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849044037128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062836

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00849044037128]

Moist Heat or Steam Sterilization

[00849044037128]

Moist Heat or Steam Sterilization

[00849044037128]

Moist Heat or Steam Sterilization

[00849044037128]

Moist Heat or Steam Sterilization

[00849044037128]

Moist Heat or Steam Sterilization

[00849044037128]

Moist Heat or Steam Sterilization

[00849044037128]

Moist Heat or Steam Sterilization

[00849044037128]

Moist Heat or Steam Sterilization

[00849044037128]

Moist Heat or Steam Sterilization

[00849044037128]

Moist Heat or Steam Sterilization

[00849044037128]

Moist Heat or Steam Sterilization

[00849044037128]

Moist Heat or Steam Sterilization

[00849044037128]

Moist Heat or Steam Sterilization

[00849044037128]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-06

On-Brand Devices [CITADEL]

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• 00849044037418: 6.5mm Self-Tapping Screw, Fixed Angle, 54mm
• 00849044037401: 6.5mm Self-Tapping Screw, Fixed Angle, 51mm
• 00849044037395: 6.5mm Self-Tapping Screw, Fixed Angle, 48mm
• 00849044037388: 6.5mm Self-Tapping Screw, Fixed Angle, 45mm
• 00849044037371: 6.5mm Self-Tapping Screw, Fixed Angle, 42mm
• 00849044037364: 6.5mm Self-Tapping Screw, Fixed Angle, 39mm
• 00849044037357: 6.5mm Self-Tapping Screw, Fixed Angle, 36mm
• 00849044037340: 6.5mm Self-Tapping Screw, Fixed Angle, 33mm
• 00849044037333: 6.5mm Self-Tapping Screw, Fixed Angle, 30mm
• 00849044037326: 6.5mm Self-Tapping Screw, Fixed Angle, 28mm
• 00849044037319: 6.5mm Self-Tapping Screw, Fixed Angle, 26mm
• 00849044037302: 6.5mm Self-Tapping Screw, Fixed Angle, 24mm
• 00849044037296: 6.5mm Self-Tapping Screw, Fixed Angle, 22mm
• 00849044037289: 6.5mm Self-Tapping Screw, Variable Angle, 57mm
• 00849044037272: 6.5mm Self-Tapping Screw, Variable Angle, 54mm
• 00849044037265: 6.5mm Self-Tapping Screw, Variable Angle, 51mm
• 00849044037258: 6.5mm Self-Tapping Screw, Variable Angle, 48mm
• 00849044037241: 6.5mm Self-Tapping Screw, Variable Angle, 45mm
• 00849044037234: 6.5mm Self-Tapping Screw, Variable Angle, 42mm
• 00849044037227: 6.5mm Self-Tapping Screw, Variable Angle, 39mm
• 00849044037210: 6.5mm Self-Tapping Screw, Variable Angle, 36mm
• 00849044037203: 6.5mm Self-Tapping Screw, Variable Angle, 33mm
• 00849044037197: 6.5mm Self-tapping Screw, Variable Angle, 30mm
• 00849044037180: 6.5mm Self-tapping Screw, Variable Angle, 28mm
• 00849044037173: 6.5mm Self-tapping Screw, Variable Angle, 26mm
• 00849044037166: 6.5mm Self-tapping Screw, Variable Angle, 24mm
• 00849044037159: 6.5mm Self-tapping Screw, Variable Angle, 22mm
• 00849044037142: CITADEL 6.5mm Cannulated Screw, 57mm
• 00849044037135: CITADEL 6.5mm Cannulated Screw, 54mm
• 00849044037128: CITADEL 6.5mm Cannulated Screw, 51mm
• 00849044037111: CITADEL 6.5mm Cannulated Screw, 48mm
• 00849044037104: CITADEL 6.5mm Cannulated Screw, 45mm
• 00849044037098: CITADEL 6.5mm Cannulated Screw, 42mm
• 00849044037081: CITADEL 6.5mm Cannulated Screw, 39mm
• 00849044037074: CITADEL 6.5mm Cannulated Screw, 36mm
• 00889095039252: CITADEL 6.5mm Cannulated Screw, 22mm
• 00889095039245: CITADEL Anterior Lumbosacral Plate, 2-Level, 90mm
• 00889095039238: CITADEL Anterior Lumbosacral Plate, 2-Level, 87mm
• 00889095039221: CITADEL Anterior Lumbosacral Plate, 2-Level, 84mm
• 00889095039214: CITADEL Anterior Lumbosacral Plate, 2-Level, 81mm
• 00889095039207: CITADEL Anterior Lumbosacral Plate, 2-Level, 78mm
• 00889095039191: CITADEL Anterior Lumbosacral Plate, 2-Level, 75mm
• 00889095039184: CITADEL Anterior Lumbosacral Plate, 2-Level, 72mm
• 00889095039177: CITADEL Anterior Lumbosacral Plate, 2-Level, 69mm
• 00889095039160: CITADEL Anterior Lumbosacral Plate, 2-Level, 66mm
• 00889095039153: CITADEL Anterior Lumbosacral Plate, 2-Level, 63mm
• 00889095039146: CITADEL Anterior Lumbosacral Plate, 1-Level, 34mm
• 00889095039139: CITADEL Anterior Lumbosacral Plate, 1-Level, 32mm
• 00889095039122: CITADEL Anterior Lumbosacral Plate, 1-Level, 30mm