Duo Ti Expandable Interbody Fusion System 861-0030

GUDID M7408610030

Duo Ti Trial, 10mm, 8°

SPINEOLOGY INC.

Metallic spinal interbody fusion cage

• Primary Device ID: M7408610030
• NIH Device Record Key: 6b01a33f-9301-4d30-8e7d-0a090e15687a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duo Ti Expandable Interbody Fusion System
• Version Model Number: 86-11-19-10
• Catalog Number: 861-0030
• 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: false
• 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: 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
• 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	M7408610030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210155

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[M7408610030]

Moist Heat or Steam Sterilization

[M7408610030]

Moist Heat or Steam Sterilization

[M7408610030]

Moist Heat or Steam Sterilization

[M7408610030]

Moist Heat or Steam Sterilization

[M7408610030]

Moist Heat or Steam Sterilization

[M7408610030]

Moist Heat or Steam Sterilization

[M7408610030]

Moist Heat or Steam Sterilization

[M7408610030]

Moist Heat or Steam Sterilization

[M7408610030]

Moist Heat or Steam Sterilization

[M7408610030]

Moist Heat or Steam Sterilization

[M7408610030]

Moist Heat or Steam Sterilization

[M7408610030]

Moist Heat or Steam Sterilization

[M7408610030]

Moist Heat or Steam Sterilization

[M7408610030]

Moist Heat or Steam Sterilization

[M7408610030]

Moist Heat or Steam Sterilization

[M7408610030]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-15
• Device Publish Date: 2021-10-07

On-Brand Devices [Duo Ti Expandable Interbody Fusion System]

• M7408610048: Duo Ti Angled Trial, 16mm, 15°
• M7408610047: Duo Ti Angled Trial, 14mm, 15°
• M7408610046: Duo Ti Angled Trial, 12mm, 15°
• M7408610045: Duo Ti Angled Trial, 16mm, 8°
• M7408610044: Duo Ti Angled Trial, 14mm, 8°
• M7408610043: Duo Ti Angled Trial, 12mm, 8°
• M7408610042: Duo Ti Angled Trial, 10mm, 8°
• M7408610041: Duo Ti Angled Trial, 16mm, 0°
• M7408610040: Duo Ti Angled Trial, 14mm, 0°
• M7408610039: Duo Ti Angled Trial, 12mm, 0°
• M7408610038: Duo Ti Angled Trial, 10mm, 0°
• M7408610037: Duo Ti Angled Trial, 8mm, 0°
• M7408610036: Duo Ti Trial, 16mm, 15°
• M7408610035: Duo Ti Trial, 14mm, 15°
• M7408610034: Duo Ti Trial, 12mm, 15°
• M7408610033: Duo Ti Trial, 16mm, 8°
• M7408610032: Duo Ti Trial, 14mm, 8°
• M7408610031: Duo Ti Trial, 12mm, 8°
• M7408610030: Duo Ti Trial, 10mm, 8°
• M7408610029: Duo Ti Trial, 16mm, 0°
• M7408610028: Duo Ti Trial, 14mm, 0°
• M7408610027: Duo Ti Trial, 12mm, 0°
• M7408610026: Duo Ti Trial, 10mm, 0°
• M7408610025: Duo Ti Trial, 8mm, 0°
• M7402976016: Duo Ti, 60 x 16mm, 15°
• M7402976014: Duo Ti, 60 x 14mm, 15°
• M7402976012: Duo Ti, 60 x 12mm, 15°
• M7402975516: Duo Ti, 55 x 16mm, 15°
• M7402975514: Duo Ti, 55 x 14mm, 15°
• M7402975512: Duo Ti, 55 x 12mm, 15°
• M7402975016: Duo Ti, 50 x 16mm, 15°
• M7402975014: Duo Ti, 50 x 14mm, 15°
• M7402975012: Duo Ti, 50 x 12mm, 15°
• M7402974516: Duo Ti, 45 x 16mm, 15°
• M7402974514: Duo Ti, 45 x 14mm, 15°
• M7402974512: Duo Ti, 45 x 12mm, 15°
• M7402966016: Duo Ti, 60 x 16mm, 8°
• M7402966014: Duo Ti, 60 x 14mm, 8°
• M7402966012: Duo Ti, 60 x 12mm, 8°
• M7402966010: Duo Ti, 60 x 10mm, 8°
• M7402965516: Duo Ti, 55 x 16mm, 8°
• M7402965514: Duo Ti, 55 x 14mm, 8°
• M7402965512: Duo Ti, 55 x 12mm, 8°
• M7402965510: Duo Ti, 55 x 10mm, 8°
• M7402965016: Duo Ti, 50 x 16mm, 8°
• M7402965014: Duo Ti, 50 x 14mm, 8°
• M7402965012: Duo Ti, 50 x 12mm, 8°
• M7402965010: Duo Ti, 50 x 10mm, 8°
• M7402964516: Duo Ti, 45 x 16mm, 8°
• M7402964514: Duo Ti, 45 x 14mm, 8°