OptiMesh Expandable Interbody Fusion System 312-0003

GUDID M7403120003

Tube Twister

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 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 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 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: M7403120003
• NIH Device Record Key: 775ecdc0-67f5-405a-9810-382cddb27b36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiMesh Expandable Interbody Fusion System
• Version Model Number: 33-03-01
• Catalog Number: 312-0003
• 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	M7403120003 [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

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

Moist Heat or Steam Sterilization

[M7403120003]

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