Diverted Bone Tube 101-1081

GUDID M7401011081

SPINEOLOGY INC.

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

• Primary Device ID: M7401011081
• NIH Device Record Key: e943e96e-0f7b-44ee-b4ff-6b48bc3eec59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diverted Bone Tube
• Version Model Number: 102-11-100
• Catalog Number: 101-1081
• Company DUNS: 033014361
• Company Name: SPINEOLOGY INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7401011081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200010

FDA Product Code

• OQB: Intervertebral Body Graft Containment Device

Sterilization

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

[M7401011081]

Moist Heat or Steam Sterilization

[M7401011081]

Moist Heat or Steam Sterilization

[M7401011081]

Moist Heat or Steam Sterilization

[M7401011081]

Moist Heat or Steam Sterilization

[M7401011081]

Moist Heat or Steam Sterilization

[M7401011081]

Moist Heat or Steam Sterilization

[M7401011081]

Moist Heat or Steam Sterilization

[M7401011081]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-30
• Device Publish Date: 2022-06-22

Devices Manufactured by SPINEOLOGY INC.

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• M7404002620 - Dual Chamber Expandable Interbody Fusion System: 2024-04-12 Dual Chamber Interbody, large
• M7401001284 - Palisade Pedicular Fixation System: 2024-03-29 Stylet Wrench
• M740227005 - OptiMesh Multiplanar Expandable Interbody Fusion System: 2024-02-29 Allograft Filler Tube - Diverted
• M7404002610 - Dual Chamber Expandable Interbody Fusion System: 2024-02-29 Dual Chamber Interbody, small
• M7401001281 - Rampart One Lumbar Interbody Fusion System: 2024-02-06 Rampart Tamping Tool
• M7401001256 - OptiLIF Endo, Direct Visualization System: 2024-01-22 180mm x 6.6mm Tube