Trabecular Metal™ 06-101-01051

GUDID 03662663064682

TM-S Fusion Device

Highridge Medical, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 03662663064682
• NIH Device Record Key: eb178b56-6310-4fca-bf7b-e4e669fe4234
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trabecular Metal™
• Version Model Number: 06-101-01051
• Catalog Number: 06-101-01051
• Company DUNS: 119260394
• Company Name: Highridge Medical, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com
• Phone: +1(800)447-3625
• Email: usbrocustomerservice@highridgemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662663064682 [Primary]

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[03662663064682]

Radiation Sterilization

[03662663064682]

Radiation Sterilization

[03662663064682]

Radiation Sterilization

[03662663064682]

Radiation Sterilization

[03662663064682]

Radiation Sterilization

[03662663064682]

Radiation Sterilization

[03662663064682]

Radiation Sterilization

[03662663064682]

Radiation Sterilization

[03662663064682]

Radiation Sterilization

[03662663064682]

Radiation Sterilization

[03662663064682]

Radiation Sterilization

[03662663064682]

Radiation Sterilization

[03662663064682]

Radiation Sterilization

[03662663064682]

Radiation Sterilization

[03662663064682]

Radiation Sterilization

[03662663064682]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-13
• Device Publish Date: 2025-01-03

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• 03662663079853 - Virage® OCT: 2025-01-20 Head-to-Rod Channel Connector (Ø3.5mm/4.0mm - Ø3.5mm/4.0mm)
• 03662663079860 - Virage® OCT: 2025-01-20 Head-to-Rod Connector Tall Closure Top
• 03662663079877 - Virage® OCT: 2025-01-20 Head-to-Rod Connector Lock Nut
• 03662663080026 - Virage OCT: 2025-01-20 Head-to-Rod Connector Lock Nut Driver
• 03662663080033 - Virage OCT: 2025-01-20 Connector Forceps
• 03662663080118 - Virage OCT: 2025-01-20 Auxiliary Implant and Instrument Base
• 03662663080125 - Virage OCT: 2025-01-20 Channel Connector Caddy & Lid