ANTHEM

GUDID 00193982167318

ANTHEM Non-Locking Screw, 4.5x70mm, SS

GLOBUS MEDICAL, INC.

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

• Primary Device ID: 00193982167318
• NIH Device Record Key: a3fb3a0c-4196-4ff5-80fd-4f7530c45a54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTHEM
• Version Model Number: 2206.2070
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193982167318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213591

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00193982167318]

Moist Heat or Steam Sterilization

[00193982167318]

Moist Heat or Steam Sterilization

[00193982167318]

Moist Heat or Steam Sterilization

[00193982167318]

Moist Heat or Steam Sterilization

[00193982167318]

Moist Heat or Steam Sterilization

[00193982167318]

Moist Heat or Steam Sterilization

[00193982167318]

Moist Heat or Steam Sterilization

[00193982167318]

Moist Heat or Steam Sterilization

[00193982167318]

Moist Heat or Steam Sterilization

[00193982167318]

Moist Heat or Steam Sterilization

[00193982167318]

Moist Heat or Steam Sterilization

[00193982167318]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-09
• Device Publish Date: 2022-04-29

On-Brand Devices [ANTHEM]

• 00889095725568: ANTHEM Universal Distal Fibula Plate, 7 Hole, 126mm, Ti
• 00889095725544: ANTHEM Universal Distal Fibula Plate, 5 Hole, 101mm, Ti
• 00889095725452: ANTHEM Posterolateral Distal Fibula Plate, Right, 9 Hole, 157mm, Ti
• 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
• 00193982018146: MonoAx Locking Screw, 3.5x54mm, Blunt Tip, SS
• 00193982018122: MonoAx Locking Screw, 3.5x52mm, Blunt Tip, SS
• 00193982018085: MonoAx Locking Screw, 3.5x48mm, Blunt Tip, SS
• 00193982018061: MonoAx Locking Screw, 3.5x46mm, Blunt Tip, SS
• 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
• 00889095614442: ANTHEM Lateral Proximal Tibia Plate, Right, 20 Hole, 320mm, SS
• 00889095614435: ANTHEM Lateral Proximal Tibia Plate, Right, 18 Hole, 294mm, SS