OptiMesh Expandable Interbody Fusion System 312-0004

GUDID M7403120004

Release Driver

SPINEOLOGY INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: M7403120004
• NIH Device Record Key: 2c82d0ec-c6f5-41f1-8af5-6716c23a0248
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiMesh Expandable Interbody Fusion System
• Version Model Number: 32-01-28
• Catalog Number: 312-0004
• 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: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com
• Phone: +1(651)256-8500
• Email: info@spineology.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7403120004 [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

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

[M7403120004]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-25
• Device Publish Date: 2021-03-17

On-Brand Devices [OptiMesh Expandable Interbody Fusion System]

• M7403120055: Mesh Extender
• M7403120004: Release Driver
• M7403120003: Tube Twister
• M7403120001: Inserter
• M7403003440: OptiMesh
• M7403003032: OptiMesh
• M7403002628: OptiMesh
• M7403001012: Diverted Fill Tube
• M7403001008: Straight Fill Tube
• M7403001015: Diverted Fill Tube