Threshold V2 Pedicle Screw 550-4535

GUDID M7405504535

Pedicle Screw

SPINEOLOGY INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: M7405504535
• NIH Device Record Key: b34210a9-ae96-4442-b505-267f9fd0d49a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Threshold V2 Pedicle Screw
• Version Model Number: 10-10-78-39
• Catalog Number: 550-4535
• 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: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Length: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7405504535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172107

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

[M7405504535]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-23
• Device Publish Date: 2017-09-21

On-Brand Devices [Threshold V2 Pedicle Screw]

• M7405514550: Pedicle Screw
• M7405514545: Pedicle Screw
• M7405514540: Pedicle Screw
• M7405514535: Pedicle Screw
• M7405514530: Pedicle Screw
• M7405514525: Pedicle Screw
• M7405504550: Pedicle Screw
• M7405504545: Pedicle Screw
• M7405504540: Pedicle Screw
• M7405504535: Pedicle Screw
• M7405504530: Pedicle Screw
• M7405504525: Pedicle Screw