Threshold Solid Pedicle Screw 551-8535

GUDID M7405518535

Pedicle Screw

SPINEOLOGY INC.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: M7405518535
• NIH Device Record Key: c11dca6e-f6a9-4a76-a3d9-1bcbbe508826
• Commercial Distribution Discontinuation: 2024-07-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Threshold Solid Pedicle Screw
• Version Model Number: 10-10-80-30
• Catalog Number: 551-8535
• 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: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com
• Phone: +1(651)256-8500
• Email: jhauge@spineology.com

Device Dimensions

• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7405518535 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161694

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

[M7405518535]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-23
• Device Publish Date: 2016-08-03

On-Brand Devices [Threshold Solid Pedicle Screw]

• M7405518599: Pedicle Screw
• M7405518590: Pedicle Screw
• M7405518580: Pedicle Screw
• M7405518570: Pedicle Screw
• M7405518565: Pedicle Screw
• M7405518560: Pedicle Screw
• M7405518555: Pedicle Screw
• M7405518550: Pedicle Screw
• M7405518545: Pedicle Screw
• M7405518540: Pedicle Screw
• M7405518535: Pedicle Screw
• M7405518530: Pedicle Screw
• M7405517565: Pedicle Screw
• M7405517560: Pedicle Screw
• M7405517555: Pedicle Screw
• M7405517550: Pedicle Screw
• M7405517545: Pedicle Screw
• M7405517540: Pedicle Screw
• M7405517535: Pedicle Screw
• M7405517530: Pedicle Screw
• M7405516565: Pedicle Screw
• M7405516560: Pedicle Screw
• M7405516555: Pedicle Screw
• M7405516550: Pedicle Screw
• M7405516545: Pedicle Screw
• M7405516540: Pedicle Screw
• M7405516535: Pedicle Screw
• M7405516530: Pedicle Screw
• M7405515560: Pedicle Screw
• M7405515555: Pedicle Screw
• M7405515550: Pedicle Screw
• M7405515545: Pedicle Screw
• M7405515540: Pedicle Screw
• M7405515535: Pedicle Screw
• M7405515530: Pedicle Screw
• M7405515050: Pedicle Screw
• M7405515045: Pedicle Screw
• M7405515040: Pedicle Screw
• M7405515035: Pedicle Screw
• M7405515030: Pedicle Screw
• M7405508599: Pedicle Screw
• M7405508590: Pedicle Screw
• M7405508580: Pedicle Screw
• M7405508570: Pedicle Screw
• M7405508565: Pedicle Screw
• M7405508560: Pedicle Screw
• M7405508555: Pedicle Screw
• M7405508550: Pedicle Screw
• M7405508545: Pedicle Screw
• M7405508540: Pedicle Screw