CITADEL

GUDID 00849044037326

6.5mm Self-Tapping Screw, Fixed Angle, 28mm

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 ID: 00849044037326
• NIH Device Record Key: ae697e9d-3061-4fb4-b030-a75544fce51f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CITADEL
• Version Model Number: 130.828
• 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: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter
• Length: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849044037326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062407

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00849044037326]

Moist Heat or Steam Sterilization

[00849044037326]

Moist Heat or Steam Sterilization

[00849044037326]

Moist Heat or Steam Sterilization

[00849044037326]

Moist Heat or Steam Sterilization

[00849044037326]

Moist Heat or Steam Sterilization

[00849044037326]

Moist Heat or Steam Sterilization

[00849044037326]

Moist Heat or Steam Sterilization

[00849044037326]

Moist Heat or Steam Sterilization

[00849044037326]

Moist Heat or Steam Sterilization

[00849044037326]

Moist Heat or Steam Sterilization

[00849044037326]

Moist Heat or Steam Sterilization

[00849044037326]

Moist Heat or Steam Sterilization

[00849044037326]

Moist Heat or Steam Sterilization

[00849044037326]

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

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