VIA Spinous Process Fixation System 440-0035

GUDID M7404400035

17mm Rasp

SPINEOLOGY INC.

Bone file/rasp, manual, reusable

• Primary Device ID: M7404400035
• NIH Device Record Key: f6f38658-91a9-4d6d-82f3-e41db9ba5831
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIA Spinous Process Fixation System
• Version Model Number: 34-06-18
• Catalog Number: 440-0035
• Company DUNS: 033014361
• Company Name: SPINEOLOGY INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter
• Device Size Text, specify: 0
• Length: 17 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7404400035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142213

FDA Product Code

• PEK: Spinous process plate

Sterilization

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

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

[M7404400035]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-23
• Device Publish Date: 2015-02-25

On-Brand Devices [VIA Spinous Process Fixation System]

• M7404400046: Sterilzation Tray Base
• M7404400042: 7mm Dilator
• M7404400041: 17mm Modular Inserter
• M7404400040: 15mm Modular Inserter
• M7404400039: 13mm Modular Inserter
• M7404400038: 11mm Modular Inserter
• M7404400037: 9mm Modular Inserter
• M7404400036: Removal Tool
• M7404400035: 17mm Rasp
• M7404400034: 15mm Rasp
• M7404400033: 11mm Rasp
• M7404400032: 3" Distractor
• M7404400030: Final Tightner
• M7404400028: Implant Compressor
• M7404400027: Sterilzation Tray Base
• M7404400026: Sterilzation Pullout Tray
• M7404400024: Sterilization Lid
• M7404400023: Implant Inserter
• M7404400022: Implant Setting Block
• M7404400021: 5mm Dilator
• M7404400020: 13mm Rasp
• M7404400019: 9mm Rasp
• M7404400018: Trox Driver
• M7404400015: 17mm Trial
• M7404400014: 15mm Trial
• M7404400013: 13mm Trial
• M7404400012: 11mm Trial
• M7404400011: 9mm Trial
• M7404400006: Left and Right Female Plate
• M7404400005: Male Plate
• M7404400004: Male Plate
• M7404400003: Male Plate
• M7404400002: Male Plate
• M7404400001: Male Plate