Fortress Set Screw 640-6000

GUDID M7406406000

Set Screw

SPINEOLOGY INC.

Spinal bone set screw

• Primary Device ID: M7406406000
• NIH Device Record Key: ba7def8c-0d10-4b93-8b06-8f33155a49d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortress Set Screw
• Version Model Number: 10-10-53-2
• Catalog Number: 640-6000
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M7406406000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140010

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

[M7406406000]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-22
• Device Publish Date: 2014-12-05

On-Brand Devices [Fortress Set Screw]

• M7406406000: Set Screw
• M7406405000: Set Screw