Fortress Rod 640-0085

GUDID M7406400085

Medium Rod

SPINEOLOGY INC.

Bone-screw internal spinal fixation system rod

• Primary Device ID: M7406400085
• NIH Device Record Key: af27a33a-582b-4e9b-bfc4-5ef76ed6620e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fortress Rod
• Version Model Number: 10-10-51-1
• Catalog Number: 640-0085
• 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 Dimensions

• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0
• Length: 220 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7406400085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140010

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[M7406400085]

Ethylene Oxide

[M7406400085]

Ethylene Oxide

[M7406400085]

Ethylene Oxide

[M7406400085]

Ethylene Oxide

[M7406400085]

Ethylene Oxide

[M7406400085]

Ethylene Oxide

[M7406400085]

Ethylene Oxide

[M7406400085]

Ethylene Oxide

[M7406400085]

Ethylene Oxide

[M7406400085]

Ethylene Oxide

[M7406400085]

Ethylene Oxide

[M7406400085]

Ethylene Oxide

[M7406400085]

Ethylene Oxide

[M7406400085]

Ethylene Oxide

[M7406400085]

Ethylene Oxide

[M7406400085]

Ethylene Oxide

[M7406400085]

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 Rod]

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• M7406407060: Pedicle Screw
• M7406407055: Pedicle Screw
• M7406407050: Pedicle Screw
• M7406407045: Pedicle Screw
• M7406407040: Pedicle Screw
• M7406407035: Pedicle Screw
• M7406407030: Pedicle Screw
• M7406407025: Pedicle Screw
• M7406400200: Long Rod
• M7406400120: Medium Rod
• M7406400110: Medium Rod
• M7406400100: Medium Rod
• M7406400090: Medium Rod
• M7406400085: Medium Rod
• M7406400080: Short Rod
• M7406400075: Short Rod
• M7406400070: Short Rod
• M7406400065: Short Rod
• M7406400060: Short Rod
• M7406400055: Short Rod
• M7406400050: Short Rod
• M7406400045: Short Rod
• M7406400040: Short Rod
• M7406400035: Short Rod
• M7406400030: Short Rod
• M7406400025: Short Rod