CCD™ Spinal System

GUDID 00673978111544

SCREW C8100KT CCD TI M10 PLUG KOREA

MEDTRONIC SOFAMOR DANEK, INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00673978111544
• NIH Device Record Key: a975e0c4-dc56-4987-b9d5-62ae48f6b66a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CCD™ Spinal System
• Version Model Number: C8100KT
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00673978111544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955365

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

Moist Heat or Steam Sterilization

[00673978111544]

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 [CCD™ Spinal System]

• 00673978111551: SCREW C8100T CCD TI MIO PLUG
• 00673978111544: SCREW C8100KT CCD TI M10 PLUG KOREA
• 00673978108599: SCREW C3074L70 CDH CNICL SAC BLOCK 7X70
• 00673978108551: SCREW C3074L60 CDH CNICL SAC BLOCK 7X60
• 00673978108537: SCREW C3074L55 CDH CNICL SAC BLOCK 7X55
• 00673978108513: SCREW C3074L50 CDH CNICAL SAC BLOCK 7X50
• 00673978108490: SCREW C3074L45 CDH CNICL SAC BLOCK 7X45
• 00673978108476: SCREW C3074L40 CDH CNICL SAC BLOCK 7X40
• 00673978108452: SCREW C3074L35 CDH CNICL SAC BLOCK 7X35