COALITION MIS

GUDID 00889095345674

COALITION MIS Spacer, 12 x 14, 7°, 10mm

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00889095345674
• NIH Device Record Key: debdbe95-70f6-48f2-b7f5-b32fa74e5495
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COALITION MIS
• Version Model Number: 3136.1110
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095345674 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151939

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[00889095345674]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-02-27

On-Brand Devices [COALITION MIS]

• 00889095306200: Freehand Inserter, 15x18mm
• 00889095306194: Freehand Inserter, Standard
• 00889095305425: Anchor Removal Tool
• 00889095390001: COALITION MIS Anchor, 13mm
• 00889095389999: COALITION MIS Anchor, 11mm
• 00889095358988: COALITION MIS Anchor, 17mm
• 00889095358971: COALITION MIS Anchor, 16mm
• 00889095358964: COALITION MIS Anchor, 15mm
• 00889095358957: COALITION MIS Anchor, 14mm
• 00889095358940: COALITION MIS Anchor, 12mm
• 00889095346220: COALITION MIS Spacer, 15 x 18, 12°, 12mm
• 00889095346213: COALITION MIS Spacer, 15 x 18, 12°, 11mm
• 00889095346206: COALITION MIS Spacer, 15 x 18, 12°, 10mm
• 00889095346190: COALITION MIS Spacer, 15 x 18, 12°, 9mm
• 00889095346183: COALITION MIS Spacer, 15 x 18, 12°, 8mm
• 00889095346176: COALITION MIS Spacer, 15 x 18, 12°, 7mm
• 00889095346169: COALITION MIS Spacer, 15 x 18, 12°, 6mm
• 00889095346152: COALITION MIS Spacer, 15 x 18, 7°, 12mm
• 00889095346145: COALITION MIS Spacer, 15 x 18, 7°, 11mm
• 00889095346138: COALITION MIS Spacer, 15 x 18, 7°, 10mm
• 00889095346121: COALITION MIS Spacer, 15 x 18, 7°, 9mm
• 00889095346114: COALITION MIS Spacer, 15 x 18, 7°, 8mm
• 00889095346107: COALITION MIS Spacer, 15 x 18, 7°, 7mm
• 00889095346091: COALITION MIS Spacer, 15 x 18, 7°, 6mm
• 00889095346084: COALITION MIS Spacer, 15 x 18, 7°, 5mm
• 00889095346077: COALITION MIS Spacer, 15 x 18, 0°, 12mm
• 00889095346060: COALITION MIS Spacer, 15 x 18, 0°, 11mm
• 00889095346053: COALITION MIS Spacer, 15 x 18, 0°, 10mm
• 00889095346046: COALITION MIS Spacer, 15 x 18, 0°, 9mm
• 00889095346039: COALITION MIS Spacer, 15 x 18, 0°, 8mm
• 00889095346022: COALITION MIS Spacer, 15 x 18, 0°, 7mm
• 00889095346015: COALITION MIS Spacer, 15 x 18, 0°, 6mm
• 00889095346008: COALITION MIS Spacer, 15 x 18, 0°, 5mm
• 00889095345995: COALITION MIS Spacer, 14 x 16, 12°, 12mm
• 00889095345988: COALITION MIS Spacer, 14 x 16, 12°, 11mm
• 00889095345971: COALITION MIS Spacer, 14 x 16, 12°, 10mm
• 00889095345964: COALITION MIS Spacer, 14 x 16, 12°, 9mm
• 00889095345957: COALITION MIS Spacer, 14 x 16, 12°, 8mm
• 00889095345940: COALITION MIS Spacer, 14 x 16, 12°, 7mm
• 00889095345933: COALITION MIS Spacer, 14 x 16, 12°, 6mm
• 00889095345926: COALITION MIS Spacer, 14 x 16, 7°, 12mm
• 00889095345919: COALITION MIS Spacer, 14 x 16, 7°, 11mm
• 00889095345902: COALITION MIS Spacer, 14 x 16, 7°, 10mm
• 00889095345896: COALITION MIS Spacer, 14 x 16, 7°, 9mm
• 00889095345889: COALITION MIS Spacer, 14 x 16, 7°, 8mm
• 00889095345872: COALITION MIS Spacer, 14 x 16, 7°, 7mm
• 00889095345865: COALITION MIS Spacer, 14 x 16, 7°, 6mm
• 00889095345858: COALITION MIS Spacer, 14 x 16, 7°, 5mm
• 00889095345841: COALITION MIS Spacer, 14 x 16, 0°, 12mm
• 00889095345834: COALITION MIS Spacer, 14 x 16, 0°, 11mm