CITADEL

GUDID 00849044037227

6.5mm Self-Tapping Screw, Variable Angle, 39mm

GLOBUS MEDICAL, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00849044037227
• NIH Device Record Key: 7bef409a-30df-4b24-a63c-0076792b2384
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CITADEL
• Version Model Number: 130.639
• 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: 39 Millimeter
• Length: 39 Millimeter
• Length: 39 Millimeter
• Length: 39 Millimeter
• Length: 39 Millimeter
• Length: 39 Millimeter
• Length: 39 Millimeter
• Length: 39 Millimeter
• Length: 39 Millimeter
• Length: 39 Millimeter
• Length: 39 Millimeter
• Length: 39 Millimeter
• Length: 39 Millimeter
• Length: 39 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849044037227 [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

[00849044037227]

Moist Heat or Steam Sterilization

[00849044037227]

Moist Heat or Steam Sterilization

[00849044037227]

Moist Heat or Steam Sterilization

[00849044037227]

Moist Heat or Steam Sterilization

[00849044037227]

Moist Heat or Steam Sterilization

[00849044037227]

Moist Heat or Steam Sterilization

[00849044037227]

Moist Heat or Steam Sterilization

[00849044037227]

Moist Heat or Steam Sterilization

[00849044037227]

Moist Heat or Steam Sterilization

[00849044037227]

Moist Heat or Steam Sterilization

[00849044037227]

Moist Heat or Steam Sterilization

[00849044037227]

Moist Heat or Steam Sterilization

[00849044037227]

Moist Heat or Steam Sterilization

[00849044037227]

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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• 00849044037401: 6.5mm Self-Tapping Screw, Fixed Angle, 51mm
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• 00849044037340: 6.5mm Self-Tapping Screw, Fixed Angle, 33mm
• 00849044037333: 6.5mm Self-Tapping Screw, Fixed Angle, 30mm
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• 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
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• 00849044037166: 6.5mm Self-tapping Screw, Variable Angle, 24mm
• 00849044037159: 6.5mm Self-tapping Screw, Variable Angle, 22mm
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• 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
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• 00889095039153: CITADEL Anterior Lumbosacral Plate, 2-Level, 63mm
• 00889095039146: CITADEL Anterior Lumbosacral Plate, 1-Level, 34mm
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