Threshold Curved Rod 530-2080

GUDID M7405302080

Curved Rod

SPINEOLOGY INC.

Bone-screw internal spinal fixation system rod

• Primary Device ID: M7405302080
• NIH Device Record Key: 5cd6b169-b7c5-40c1-ad0f-2d0f922a250f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Threshold Curved Rod
• Version Model Number: 10-10-07-30
• Catalog Number: 530-2080
• 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

Device Dimensions

• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0
• Length: 80 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7405302080 [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

[M7405302080]

Ethylene Oxide

[M7405302080]

Ethylene Oxide

[M7405302080]

Ethylene Oxide

[M7405302080]

Ethylene Oxide

[M7405302080]

Ethylene Oxide

[M7405302080]

Ethylene Oxide

[M7405302080]

Ethylene Oxide

[M7405302080]

Ethylene Oxide

[M7405302080]

Ethylene Oxide

[M7405302080]

Ethylene Oxide

[M7405302080]

Ethylene Oxide

[M7405302080]

Ethylene Oxide

[M7405302080]

Ethylene Oxide

[M7405302080]

Ethylene Oxide

[M7405302080]

Ethylene Oxide

[M7405302080]

Ethylene Oxide

[M7405302080]

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

On-Brand Devices [Threshold Curved Rod]

• M7405304200: Long Fixed Rods
• M7405304180: Long Fixed Rods
• M7405304160: Long Fixed Rods
• M7405304140: Long Fixed Rods
• M7405302120: Curved Rod
• M7405302110: Curved Rod
• M7405302100: Curved Rod
• M7405302090: Curved Rod
• M7405302080: Curved Rod
• M7405302075: Curved Rod
• M7405302070: Curved Rod
• M7405302065: Curved Rod
• M7405302060: Curved Rod
• M7405302055: Curved Rod
• M7405302050: Curved Rod
• M7405302045: Curved Rod
• M7405302040: Curved Rod
• M7405302035: Curved Rod
• M7405302030: Curved Rod