ANTHEM

GUDID 00889095411386

Locking Screw, 2.5 X 21mm, CoCr

GLOBUS MEDICAL, INC.

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

• Primary Device ID: 00889095411386
• NIH Device Record Key: 573f5fa4-4f18-4e73-b7a2-a874a68305b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTHEM
• Version Model Number: 7171.5521
• 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: 21 Millimeter
• Outer Diameter: 2.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095411386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163361

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00889095411386]

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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• 00889095725438: ANTHEM Posterolateral Distal Fibula Plate, Right, 7 Hole, 131mm, Ti
• 00889095725414: ANTHEM Posterolateral Distal Fibula Plate, Right, 5 Hole, 106mm, Ti
• 00889095725407: ANTHEM Posterolateral Distal Fibula Plate, Right, 4 Hole, 90mm, Ti
• 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
• 00889095725018: ANTHEM Lateral Distal Fibula Plate, Left, 4 Hole, 88mm, Ti
• 00889095724967: ANTHEM Hook Plate, 4 Hole, 66mm, Ti
• 00193982018177: MonoAx Locking Screw, 3.5x58mm, Blunt Tip, SS
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• 00193982018047: MonoAx Locking Screw, 3.5x44mm, Blunt Tip, SS
• 00193982018023: MonoAx Locking Screw, 3.5x42mm, Blunt Tip, SS
• 00193982017682: MonoAx Locking Screw, 3.5x56mm, Blunt Tip, SS
• 00889095406375: Non-Locking Screw, 3.5 X 85mm, SS
• 00889095403404: ANTHEM Reconstruction Plate, 12 Hole, 142mm, SS
• 00889095400540: ANTHEM 7 Plate, Wide, Right, 5 Hole, SS
• 00889095400267: ANTHEM 7 Plate, Wide, Left, 5 Hole, SS
• 00889095725513: ANTHEM Posterolateral Distal Fibula Plate, Right, 15 Hole, 233mm, Ti
• 00889095725490: ANTHEM Posterolateral Distal Fibula Plate, Right, 13 Hole, 208mm, Ti
• 00889095725476: ANTHEM Posterolateral Distal Fibula Plate, Right, 11 Hole, 182mm, Ti
• 00889095725391: ANTHEM Posterolateral Distal Fibula Plate, Right, 3 Hole, 70mm, Ti
• 00889095725384: ANTHEM Lateral Distal Fibula Plate, Right, 15 Hole, 228mm, Ti
• 00889095725360: ANTHEM Lateral Distal Fibula Plate, Right, 13 Hole, 203mm, Ti
• 00889095725346: ANTHEM Lateral Distal Fibula Plate, Right, 11 Hole, 177mm, Ti
• 00889095725261: ANTHEM Lateral Distal Fibula Plate, Right, 3 Hole, 75mm, Ti
• 00889095725254: ANTHEM Posterolateral Distal Fibula Plate, Left, 15 Hole, 233mm, Ti
• 00889095725230: ANTHEM Posterolateral Distal Fibula Plate, Left, 13 Hole, 208mm, Ti
• 00889095725216: ANTHEM Posterolateral Distal Fibula Plate, Left, 11 Hole, 182mm, Ti
• 00889095725131: ANTHEM Posterolateral Distal Fibula Plate, Left, 3 Hole, 70mm, Ti
• 00889095725124: ANTHEM Lateral Distal Fibula Plate, Left, 15 Hole, 228mm, Ti
• 00889095725100: ANTHEM Lateral Distal Fibula Plate, Left, 13 Hole, 203mm, Ti
• 00889095725087: ANTHEM Lateral Distal Fibula Plate, Left, 11 Hole, 177mm, Ti
• 00889095725001: ANTHEM Lateral Distal Fibula Plate, Left, 3 Hole, 75mm, Ti
• 00889095738155: Drill Sleeve, Long
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