Threshold Pedicular Fixation System 550-0200

GUDID M7405500200

Straight Rod

SPINEOLOGY INC.

Bone-screw internal spinal fixation system rod

• Primary Device ID: M7405500200
• NIH Device Record Key: 4bd462ce-60b5-4b41-923c-22170d5548a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Threshold Pedicular Fixation System
• Version Model Number: 10-10-56-8
• Catalog Number: 550-0200
• 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)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com
• Phone: +1(651)259-8500
• Email: info@spineology.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter
• Device Size Text, specify: 0
• Length: 200 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7405500200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170251

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[M7405500200]

Ethylene Oxide

[M7405500200]

Ethylene Oxide

[M7405500200]

Ethylene Oxide

[M7405500200]

Ethylene Oxide

[M7405500200]

Ethylene Oxide

[M7405500200]

Ethylene Oxide

[M7405500200]

Ethylene Oxide

[M7405500200]

Ethylene Oxide

[M7405500200]

Ethylene Oxide

[M7405500200]

Ethylene Oxide

[M7405500200]

Ethylene Oxide

[M7405500200]

Ethylene Oxide

[M7405500200]

Ethylene Oxide

[M7405500200]

Ethylene Oxide

[M7405500200]

Ethylene Oxide

[M7405500200]

Ethylene Oxide

[M7405500200]

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: 2017-04-25

On-Brand Devices [Threshold Pedicular Fixation System]

• M7405300097: Tower Wrench
• M7405300096: Tower Socket
• M7405300095: Fixed Jaws
• M7405300094: Fixed Rod Holder
• M7405300047: Distractor
• M7405300046: Compressor
• M7405300044: Open Counter Torque
• M7405300043: Final Driver (S/N: )
• M7405300040: Internal Rod Reducer
• M7405300037: Set Screw Placer
• M7405300036: Extension Reattachment
• M7405300034: Counter Torque
• M7405300033: Extension Pivot
• M7405300031: External Reducer
• M7405300016: Dilator Four
• M7405300015: Dilator Three
• M7405300014: Dilator Three (threaded)
• M7405300013: Dilator Two
• M7405300012: Dilator One
• M7405300006: Cannulated Rod Pusher
• M7405300005: AWL Handle
• M7405300004: AWL Cap
• M7405300003: AWL Stylet
• M7405300002: Cannulated AWL Shaft
• M7405500045: Rod Bender
• M7405501500: Straight Rod
• M7405501400: Straight Rod
• M7405500200: Straight Rod
• M7405500180: Straight Rod
• M7405500160: Straight Rod
• M7405500140: Straight Rod
• M7405500120: Straight Rod
• M7405500100: Straight Rod
• M7405300041: Ratcheting Axial Handle
• M7405300091: NiTi Guide Pin, 1.4mm x 610mm Blunt
• M7405300090: NiTi Guide Pin, 1.4mm x 610mm Trocar/Round
• M7405300089: Guide Pin, 1.4mm x 508mm Trocar/Round
• M7405300088: Guide Pin, 1.4mm x 508mm Trocar/Round Threaded
• M7405300087: Guide Pin, 1.4mm x 508mm Round/Round
• M7405530043: In-Situ Bender
• M7405530042: In-Situ Bender