Threshold Pedicle Screw 530-8565

GUDID M7405308565

Pedicle Screw

SPINEOLOGY INC.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: M7405308565
• NIH Device Record Key: 20e701e4-de7c-4af3-ba0e-597b1ab8f223
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Threshold Pedicle Screw
• Version Model Number: 10-10-09-36
• Catalog Number: 530-8565
• 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 Dimensions

• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter
• Device Size Text, specify: 0
• Length: 65 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7405308565 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143403

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

Ethylene Oxide

[M7405308565]

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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• 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