OptiMesh Navigation Instruments 161-0050

GUDID M7401610050

Cannulated Dilator

SPINEOLOGY INC.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: M7401610050
• NIH Device Record Key: e8c926c9-ba0f-4536-949b-a6602c907423
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiMesh Navigation Instruments
• Version Model Number: 16-09-07
• Catalog Number: 161-0050
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7401610050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251943

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[M7401610050]

Moist Heat or Steam Sterilization

[M7401610050]

Moist Heat or Steam Sterilization

[M7401610050]

Moist Heat or Steam Sterilization

[M7401610050]

Moist Heat or Steam Sterilization

[M7401610050]

Moist Heat or Steam Sterilization

[M7401610050]

Moist Heat or Steam Sterilization

[M7401610050]

Moist Heat or Steam Sterilization

[M7401610050]

Moist Heat or Steam Sterilization

[M7401610050]

Moist Heat or Steam Sterilization

[M7401610050]

Moist Heat or Steam Sterilization

[M7401610050]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-25
• Device Publish Date: 2025-12-17

On-Brand Devices [OptiMesh Navigation Instruments]

• M7401610053: Wrench
• M7401610051: Tightener
• M7401610070: Impact Cap Snap Lock
• M7401610050: Cannulated Dilator
• M7401610041: Navigation Portal Head