Threshold Pedicle Screw 551-7570

GUDID M7405517570

Pedicle Screw

SPINEOLOGY INC.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: M7405517570
• NIH Device Record Key: 07905068-e8f8-4605-99f1-b0d67dd4ebbd
• Commercial Distribution Discontinuation: 2024-07-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Threshold Pedicle Screw
• Version Model Number: 10-10-80-87
• Catalog Number: 551-7570
• 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
• 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
• 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

• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Length: 70 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7405517570 [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

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

Ethylene Oxide

[M7405517570]

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 Pedicle Screw]

• M7406307530: Pedicle Screw
• M7406306555: Pedicle Screw
• M7405517599: Pedicle Screw
• M7405517590: Pedicle Screw
• M7405517580: Pedicle Screw
• M7405517570: Pedicle Screw
• M7405507599: Pedicle Screw
• M7405507590: Pedicle Screw
• M7405507580: Pedicle Screw
• M7405507570: Pedicle Screw
• M7405308590: Pedicle Screw
• M7405308580: Pedicle Screw
• M7405308570: Pedicle Screw
• M7405308565: Pedicle Screw
• M7405308560: Pedicle Screw
• M7405308555: Pedicle Screw
• M7405308550: Pedicle Screw
• M7405308545: Pedicle Screw
• M7405308540: Pedicle Screw
• M7405308535: Pedicle Screw
• M7405308530: Pedicle Screw
• M7405308510: Pedicle Screw
• M7405307565: Pedicle Screw
• M7405307560: Pedicle Screw
• M7405307555: Pedicle Screw
• M7405307550: Pedicle Screw
• M7405307545: Pedicle Screw
• M7405307540: Pedicle Screw
• M7405307535: Pedicle Screw
• M7405306565: Pedicle Screw
• M7405306560: Pedicle Screw
• M7405306550: Pedicle Screw
• M7405306545: Pedicle Screw
• M7405306540: Pedicle Screw
• M7405306535: Pedicle Screw
• M7405306530: Pedicle Screw
• M7405305560: Pedicle Screw
• M7405305555: Pedicle Screw
• M7405305550: Pedicle Screw
• M7405305545: Pedicle Screw
• M7405305540: Pedicle Screw
• M7405305535: Pedicle Screw
• M7405305530: Pedicle Screw
• M7405305050: Pedicle Screw
• M7405305045: Pedicle Screw
• M7405305040: Pedicle Screw
• M7405305035: Pedicle Screw
• M7405305030: Pedicle Screw