T2 SCEPTOR™ Spinal System

GUDID 00613994218834

MESH 9352215 22MM ENDCAP 15 DEGREE

MEDTRONIC SOFAMOR DANEK, INC.

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• Primary Device ID: 00613994218834
• NIH Device Record Key: 0f8b893b-27b9-433d-b04b-3745efbe5615
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T2 SCEPTOR™ Spinal System
• Version Model Number: 9352215
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994218834 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063491

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

Moist Heat or Steam Sterilization

[00613994218834]

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: 2015-08-19

On-Brand Devices [T2 SCEPTOR™ Spinal System]

• 00613994218872: MESH 9352515 25MM ENDCAP 15 DEGREE
• 00613994218858: MESH 9352504 25MM ENDCAP 4 DEGREE
• 00613994218841: MESH 9352500 25MM ENDCAP 0 DEGREE
• 00613994218834: MESH 9352215 22MM ENDCAP 15 DEGREE
• 00613994218827: MESH 9352208 22MM ENDCAP 8 DEGREE
• 00613994218810: MESH 9352204 22MM ENDCAP 4 DEGREE
• 00613994218803: MESH 9352200 22MM ENDCAP 0 DEGREE
• 00613994218797: MESH 9351915 19MM ENDCAP 15 DEGREE
• 00613994218780: MESH 9351908 19MM ENDCAP 8 DEGREE
• 00613994218773: MESH 9351904 19MM ENDCAP 4 DEGREE