Threshold Set Screw 530-0001

GUDID M7405300001

Set Screw

SPINEOLOGY INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: M7405300001
• NIH Device Record Key: 16b770c7-c8db-4884-946a-f8d2b821e39e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Threshold Set Screw
• Version Model Number: 10-10-12
• Catalog Number: 530-0001
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M7405300001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143403

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

Ethylene Oxide

[M7405300001]

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: 2015-01-09

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• M7401001336 - OptiMesh Multiplanar Expandable Interbody Fusion System: 2025-07-08 TLIF Portal Anchor, Midline 4mm
• M7401001338 - OptiMesh Multiplanar Expandable Interbody Fusion System: 2025-07-08 TLIF Portal Anchor, Angled 4mm
• M7401001339 - OptiMesh Multiplanar Expandable Interbody Fusion System: 2025-07-08 Modified Portal Stem