Threshold V2 Pedicular Fixation System 570-5545

GUDID M7405705545

Reduction Screw, Uncoated

SPINEOLOGY INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: M7405705545
• NIH Device Record Key: 1b3db28b-537a-4591-a95c-b3962637f7b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Threshold V2 Pedicular Fixation System
• Version Model Number: 10-10-83-9
• Catalog Number: 570-5545
• 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)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com
• Phone: +1(651)259-8500
• Email: jhauge@spineology.com

Device Dimensions

• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Length: 45 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7405705545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170255

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

Ethylene Oxide

[M7405705545]

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: 2017-04-25

On-Brand Devices [Threshold V2 Pedicular Fixation System]

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• M7405708590: Reduction Screw, Uncoated
• M7405708580: Reduction Screw, Uncoated
• M7405708570: Reduction Screw, Uncoated
• M7405708565: Reduction Screw, Uncoated
• M7405708560: Reduction Screw, Uncoated
• M7405708555: Reduction Screw, Uncoated
• M7405708550: Reduction Screw, Uncoated
• M7405708545: Reduction Screw, Uncoated
• M7405708540: Reduction Screw, Uncoated
• M7405708535: Reduction Screw, Uncoated
• M7405708530: Reduction Screw, Uncoated
• M7405707565: Reduction Screw, Uncoated
• M7405707560: Reduction Screw, Uncoated
• M7405707555: Reduction Screw, Uncoated
• M7405707550: Reduction Screw, Uncoated
• M7405707545: Reduction Screw, Uncoated
• M7405707540: Reduction Screw, Uncoated
• M7405707535: Reduction Screw, Uncoated
• M7405707530: Reduction Screw, Uncoated
• M7405706565: Reduction Screw, Uncoated
• M7405706560: Reduction Screw, Uncoated
• M7405706555: Reduction Screw, Uncoated
• M7405706550: Reduction Screw, Uncoated
• M7405706545: Reduction Screw, Uncoated
• M7405706540: Reduction Screw, Uncoated
• M7405706535: Reduction Screw, Uncoated
• M7405706530: Reduction Screw, Uncoated
• M7405705560: Reduction Screw, Uncoated
• M7405705555: Reduction Screw, Uncoated
• M7405705550: Reduction Screw, Uncoated
• M7405705545: Reduction Screw, Uncoated
• M7405705540: Reduction Screw, Uncoated
• M7405705535: Reduction Screw, Uncoated
• M7405705530: Reduction Screw, Uncoated
• M7405705050: Reduction Screw, Uncoated
• M7405705045: Reduction Screw, Uncoated
• M7405705040: Reduction Screw, Uncoated
• M7405705035: Reduction Screw, Uncoated
• M7405705030: Reduction Screw, Uncoated