CD Horizon® ProLock™ Crosslink® Plate System

GUDID 00643169578401

MODULE 7062307 5.5/6.0 IMPLANT MODULE

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 00643169578401
• NIH Device Record Key: ad018c90-495d-407d-b5c8-e45a44b4f1cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD Horizon® ProLock™ Crosslink® Plate System
• Version Model Number: 7062307
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169578401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153589

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

[00643169578401]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-17
• Device Publish Date: 2023-02-09

On-Brand Devices [CD Horizon® ProLock™ Crosslink® Plate System]

• 00643169578418: LID 7062308 5.5/6.0 IMPLANT MODULE LID
• 00643169578401: MODULE 7062307 5.5/6.0 IMPLANT MODULE
• 00643169578371: TRAY 7062302 PROLOCK INSTRUMENT TRAY
• 00643169578364: TRAY 7062301 PROLOCK IMPLANT TRAY