CD Horizon® ProLock™ Crosslink® Plate System

GUDID 00643169578364

TRAY 7062301 PROLOCK IMPLANT TRAY

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray, reusable

• Primary Device ID: 00643169578364
• NIH Device Record Key: 13208903-fd2a-466f-b9bd-b833d03dc1cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CD Horizon® ProLock™ Crosslink® Plate System
• Version Model Number: 7062301
• 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	00643169578364 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153589

FDA Product Code

• OSH: Pedicle screw spinal system, adolescent idiopathic scoliosis

Sterilization

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

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

Moist Heat or Steam Sterilization

[00643169578364]

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