ANTHEM

GUDID 00889095391114

MonoAx Locking Screw, 2.5 x 10mm, Ti

GLOBUS MEDICAL, INC.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00889095391114
• NIH Device Record Key: 983cd0b0-57cb-4b9d-a266-83c62d216a1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTHEM
• Version Model Number: 1171.5510
• 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

• Length: 10 Millimeter
• Outer Diameter: 2.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095391114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163361

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00889095391114]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-02-19
• Device Publish Date: 2018-03-24

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• 00889095725322: ANTHEM Lateral Distal Fibula Plate, Right, 9 Hole, 152mm, Ti
• 00889095725308: ANTHEM Lateral Distal Fibula Plate, Right, 7 Hole, 126mm, Ti
• 00889095725285: ANTHEM Lateral Distal Fibula Plate, Right, 5 Hole, 101mm, Ti
• 00889095725278: ANTHEM Lateral Distal Fibula Plate, Right, 4 Hole, 88mm, Ti
• 00889095725193: ANTHEM Posterolateral Distal Fibula Plate, Left, 9 Hole, 157mm, Ti
• 00889095725179: ANTHEM Posterolateral Distal Fibula Plate, Left, 7 Hole, 131mm, Ti
• 00889095725155: ANTHEM Posterolateral Distal Fibula Plate, Left, 5 Hole, 106mm, Ti
• 00889095725148: ANTHEM Posterolateral Distal Fibula Plate, Left, 4 Hole, 90mm, Ti
• 00889095725063: ANTHEM Lateral Distal Fibula Plate, Left, 9 hole, 152mm, Ti
• 00889095725049: ANTHEM Lateral Distal Fibula Plate, Left, 7 Hole, 126mm, Ti
• 00889095725025: ANTHEM Lateral Distal Fibula Plate, Left, 5 Hole, 101mm, Ti
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• 00889095725384: ANTHEM Lateral Distal Fibula Plate, Right, 15 Hole, 228mm, Ti
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• 00889095725124: ANTHEM Lateral Distal Fibula Plate, Left, 15 Hole, 228mm, Ti
• 00889095725100: ANTHEM Lateral Distal Fibula Plate, Left, 13 Hole, 203mm, Ti
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