COLORADO 1™ Spinal System

GUDID 00673978028613

CROSSLINK 540222 5MMX22MM CRSSLNK

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00673978028613
• NIH Device Record Key: 04f01c34-61ce-4bb9-b3a7-fb55d70732d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COLORADO 1™ Spinal System
• Version Model Number: 540222
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• 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
• 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 Dimensions

• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter
• Length: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978028613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984360

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

[00673978028613]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-24

On-Brand Devices [COLORADO 1™ Spinal System]

• 00673978028712: CROSSLINK 540248 5MMX48MM CRSSLNK
• 00673978028705: CROSSLINK 540244 5MMX44MM CRSSLNK
• 00673978028699: CROSSLINK 540240 5MMX40MM CRSSLNK
• 00673978028682: CROSSLINK 540236 5MMX36MM CRSSLNK
• 00673978028668: CROSSLINK 540232 5MMX32MM CRSSLNK
• 00673978028644: CROSSLINK 540228 5MMX28MM CRSSLNK
• 00673978028637: CROSSLINK 540226 5MMX26MM CRSSLNK
• 00673978028620: CROSSLINK 540224 5MMX24MM CRSSLNK
• 00673978028613: CROSSLINK 540222 5MMX22MM CRSSLNK
• 00673978028606: CROSSLINK 540220 5MMX20MM CRSSLNK
• 00673978028217: CONNECTOR 520222 OPEN CLAMP FOR XLINK