Ramport One Pedicular Fixation System 491-0003

GUDID M7404910003

Distractor Inserter

SPINEOLOGY INC.

Orthopaedic inorganic implant inserter/extractor, reusable

• Primary Device ID: M7404910003
• NIH Device Record Key: 84c38263-dd4f-43a8-8b52-9aedf50b7339
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ramport One Pedicular Fixation System
• Version Model Number: 49-04-07
• Catalog Number: 491-0003
• 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
• 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	M7404910003 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M7404910003]

Moist Heat or Steam Sterilization

[M7404910003]

Moist Heat or Steam Sterilization

[M7404910003]

Moist Heat or Steam Sterilization

[M7404910003]

Moist Heat or Steam Sterilization

[M7404910003]

Moist Heat or Steam Sterilization

[M7404910003]

Moist Heat or Steam Sterilization

[M7404910003]

Moist Heat or Steam Sterilization

[M7404910003]

Moist Heat or Steam Sterilization

[M7404910003]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-09-11
• Device Publish Date: 2024-01-09

On-Brand Devices [Ramport One Pedicular Fixation System]

• M7404910004: Inserter Shaft
• M7404910003: Distractor Inserter