Fortress Set Screw w/ Pedicle Screw 640-1017

GUDID M7406401017

Pedicle Screw & Set Screw

SPINEOLOGY INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: M7406401017
• NIH Device Record Key: c161a6c9-6179-419d-9895-45862f51beab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortress Set Screw w/ Pedicle Screw
• Version Model Number: 10-10-48-X
• Catalog Number: 640-1017
• 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	M7406401017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140010

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

[M7406401017]

Ethylene Oxide

[M7406401017]

Ethylene Oxide

[M7406401017]

Ethylene Oxide

[M7406401017]

Ethylene Oxide

[M7406401017]

Ethylene Oxide

[M7406401017]

Ethylene Oxide

[M7406401017]

Ethylene Oxide

[M7406401017]

Ethylene Oxide

[M7406401017]

Ethylene Oxide

[M7406401017]

Ethylene Oxide

[M7406401017]

Ethylene Oxide

[M7406401017]

Ethylene Oxide

[M7406401017]

Ethylene Oxide

[M7406401017]

Ethylene Oxide

[M7406401017]

Ethylene Oxide

[M7406401017]

Ethylene Oxide

[M7406401017]

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 w/ Pedicle Screw]

• M7406401017: Pedicle Screw & Set Screw
• M7406401005: Pedicle Screw & Set Screw