Threshold V2 Reduction Screw 570-4535

GUDID M7405704535

Reduction Screw

SPINEOLOGY INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: M7405704535
• NIH Device Record Key: 21cb4ddc-779a-4129-b866-1a8f365cd370
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Threshold V2 Reduction Screw
• Version Model Number: 10-10-83-28
• Catalog Number: 570-4535
• 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	M7405704535 [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

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

Ethylene Oxide

[M7405704535]

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 Reduction Screw]

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• M7405717590: Reduction Screw
• M7405717580: Reduction Screw
• M7405717570: Reduction Screw
• M7405707599: Reduction Screw
• M7405707590: Reduction Screw
• M7405707580: Reduction Screw
• M7405707570: Reduction Screw
• M7405704550: Reduction Screw
• M7405704545: Reduction Screw
• M7405704540: Reduction Screw
• M7405704535: Reduction Screw
• M7405704530: Reduction Screw
• M7405704525: Reduction Screw