COALITION AGX

GUDID 00889095070729

COALITION AGX Plate, 20mm W, 8mm H

GLOBUS MEDICAL, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00889095070729
• NIH Device Record Key: 6036a364-2132-42ef-8697-78d2e4913246
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COALITION AGX
• Version Model Number: 1128.1528
• 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

Device Dimensions

• Width: 20 Millimeter
• Height: 8 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter
• Width: 20 Millimeter
• Height: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095070729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142218

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00889095070729]

Moist Heat or Steam Sterilization

[00889095070729]

Moist Heat or Steam Sterilization

[00889095070729]

Moist Heat or Steam Sterilization

[00889095070729]

Moist Heat or Steam Sterilization

[00889095070729]

Moist Heat or Steam Sterilization

[00889095070729]

Moist Heat or Steam Sterilization

[00889095070729]

Moist Heat or Steam Sterilization

[00889095070729]

Moist Heat or Steam Sterilization

[00889095070729]

Moist Heat or Steam Sterilization

[00889095070729]

Moist Heat or Steam Sterilization

[00889095070729]

Moist Heat or Steam Sterilization

[00889095070729]

Moist Heat or Steam Sterilization

[00889095070729]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-09-18
• Device Publish Date: 2016-01-19

On-Brand Devices [COALITION AGX]

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• 00889095300994: COALITION AGX R Spacer, 10.5x20mm, 12°, 11mm H
• 00889095300987: COALITION AGX R Spacer, 10.5x20mm, 12°, 10mm H
• 00889095300970: COALITION AGX R Spacer, 10.5x20mm, 12°, 9mm H
• 00889095300963: COALITION AGX R Spacer, 10.5x20mm, 12°, 8mm H
• 00889095300956: COALITION AGX R Spacer, 10.5x20mm, 12°, 7mm H
• 00889095300949: COALITION AGX R Spacer, 10.5x20mm, 12°, 6mm H
• 00889095300932: COALITION AGX R Spacer, 10.5x20mm, 12°, 5mm H
• 00889095089240: COALITION AGX R Spacer, 10.5x18mm, 7°, 12mm H
• 00889095089233: COALITION AGX R Spacer, 10.5x18mm, 7°, 11mm H
• 00889095089226: COALITION AGX R Spacer, 10.5x18mm,7°, 10mm H
• 00889095089219: COALITION AGX R Spacer, 10.5x18mm, 7°, 9mm H
• 00889095089202: COALITION AGX R Spacer, 10.5x18mm, 7°, 8mm H
• 00889095089196: COALITION AGX R Spacer, 10.5x18mm, 7°, 7mm H
• 00889095089189: COALITION AGX R Spacer, 10.5x18mm, 7°, 6mm H
• 00889095089172: COALITION AGX R Spacer, 10.5x18mm, 7°, 5mm H
• 00889095089165: COALITION AGX R Spacer, 10.5x20mm, 7°, 12mm H
• 00889095089158: COALITION AGX R Spacer, 10.5x20mm, 7°, 11mm H
• 00889095089141: COALITION AGX R Spacer, 10.5x20mm, 7°, 10mm H
• 00889095089134: COALITION AGX R Spacer, 10.5x20mm, 7°, 9mm H
• 00889095089127: COALITION AGX R Spacer, 10.5x20mm, 7°, 8mm H
• 00889095089110: COALITION AGX R Spacer, 10.5x20mm, 7°, 7mm H
• 00889095089103: COALITION AGX R Spacer, 10.5x20mm, 7°, 6mm H
• 00889095089097: COALITION AGX R Spacer, 10.5x20mm, 7°, 5mm H
• 00889095089080: COALITION AGX R Spacer, 10.5x20mm, 0°, 12mm H
• 00889095089073: COALITION AGX R Spacer, 10.5x20mm, 0°, 11mm H
• 00889095089066: COALITION AGX R Spacer, 10.5x20mm, 0°, 10mm H
• 00889095089059: COALITION AGX R Spacer, 10.5x20mm, 0°, 9mm H
• 00889095089042: COALITION AGX R Spacer, 10.5x20mm, 0°, 8mm H
• 00889095089035: COALITION AGX R Spacer, 10.5x20mm, 0°, 7mm H
• 00889095089028: COALITION AGX R Spacer, 10.5x20mm, 0°, 6mm H
• 00889095089011: COALITION AGX R Spacer, 10.5x20mm, 0°, 5mm H
• 00889095089004: COALITION AGX R Spacer, 10.5x18mm, 0°, 12mm H
• 00889095088991: COALITION AGX R Spacer, 10.5x18mm, 0°, 11mm H
• 00889095088984: COALITION AGX R Spacer, 10.5x18mm, 0°, 10mm H
• 00889095088977: COALITION AGX R Spacer, 10.5x18mm, 0°, 9mm H
• 00889095088960: COALITION AGX R Spacer, 10.5x18mm, 0°, 8mm H
• 00889095088953: COALITION AGX R Spacer, 10.5x18mm, 0°, 7mm H
• 00889095088946: COALITION AGX R Spacer, 10.5x18mm 0°, 6mm H
• 00889095088939: COALITION AGX R Spacer, 10.5x18mm, 0°, 5mm H
• 00889095088922: COALITION AGX R Spacer, 10x16mm, 7°, 12mm H
• 00889095088915: COALITION AGX R Spacer, 10x16mm, 7°, 11mm H
• 00889095088908: COALITION AGX R Spacer, 10x16mm, 7°, 10mm H
• 00889095088892: COALITION AGX R Spacer, 10x16mm, 7°, 9mm H
• 00889095088885: COALITION AGX R Spacer, 10x16mm, 7°, 8mm H
• 00889095088878: COALITION AGX R Spacer, 10x16mm, 7°, 7mm H
• 00889095088861: COALITION AGX R Spacer, 10x16mm, 7°, 6mm H
• 00889095088854: COALITION AGX R Spacer, 10x16mm, 7°, 5mm H
• 00889095088847: COALITION AGX R Spacer, 10x16mm, 0°, 12mm H
• 00889095088830: COALITION AGX R Spacer, 10x16mm, 0°, 11mm H