Fortress Pedicle Screw 640-8550

GUDID M7406408550

Pedicle Screw

SPINEOLOGY INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: M7406408550
• NIH Device Record Key: 0bf0aea1-b61e-4081-9b3a-7f8abee03961
• Commercial Distribution Discontinuation: 2020-11-12
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Fortress Pedicle Screw
• Version Model Number: 10-10-48-38
• Catalog Number: 640-8550
• 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
• 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: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Length: 50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7406408550 [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

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

[M7406408550]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-07-22
• Device Publish Date: 2014-12-05

On-Brand Devices [Fortress Pedicle Screw]

• M7406408599: Pedicle Screw
• M7406408590: Pedicle Screw
• M7406408580: Pedicle Screw
• M7406408570: Pedicle Screw
• M7406408565: Pedicle Screw
• M7406408560: Pedicle Screw
• M7406408555: Pedicle Screw
• M7406408550: Pedicle Screw
• M7406408545: Pedicle Screw
• M7406408540: Pedicle Screw
• M7406408535: Pedicle Screw
• M7406408530: Pedicle Screw
• M7406408525: Pedicle Screw
• M7406407565: Pedicle Screw
• M7406407560: Pedicle Screw
• M7406407555: Pedicle Screw
• M7406407550: Pedicle Screw
• M7406407545: Pedicle Screw
• M7406407540: Pedicle Screw
• M7406407535: Pedicle Screw
• M7406407530: Pedicle Screw
• M7406407525: Pedicle Screw
• M7406406565: Pedicle Screw
• M7406406560: Pedicle Screw
• M7406406555: Pedicle Screw
• M7406406550: Pedicle Screw
• M7406406545: Pedicle Screw
• M7406406540: Pedicle Screw
• M7406406535: Pedicle Screw
• M7406406530: Pedicle Screw
• M7406406525: Pedicle Screw
• M7406405560: Pedicle Screw
• M7406405555: Pedicle Screw
• M7406405550: Pedicle Screw
• M7406405545: Pedicle Screw
• M7406405540: Pedicle Screw
• M7406405535: Pedicle Screw
• M7406405530: Pedicle Screw
• M7406405525: Pedicle Screw
• M7406404550: Pedicle Screw
• M7406404545: Pedicle Screw
• M7406404540: Pedicle Screw
• M7406404535: Pedicle Screw
• M7406404530: Pedicle Screw
• M7406404525: Pedicle Screw
• M7407407065: Pedicle Screw
• M7407407060: Pedicle Screw
• M7407407055: Pedicle Screw
• M7407407050: Pedicle Screw
• M7407407045: Pedicle Screw