OptiMesh Navigation Instruments 161-0053

GUDID M7401610053

Wrench

SPINEOLOGY INC.

Surgical torque wrench, reusable

• Primary Device ID: M7401610053
• NIH Device Record Key: b5fe8678-3ae8-4586-a254-839cb037fe18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiMesh Navigation Instruments
• Version Model Number: 16-09-12
• Catalog Number: 161-0053
• Company DUNS: 033014361
• Company Name: SPINEOLOGY INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7401610053 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M7401610053]

Moist Heat or Steam Sterilization

[M7401610053]

Moist Heat or Steam Sterilization

[M7401610053]

Moist Heat or Steam Sterilization

[M7401610053]

Moist Heat or Steam Sterilization

[M7401610053]

Moist Heat or Steam Sterilization

[M7401610053]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-18
• Device Publish Date: 2025-12-10

On-Brand Devices [OptiMesh Navigation Instruments]

• M7401610053: Wrench
• M7401610051: Tightener