T2™ Spinal System

GUDID 00613994676504

CENTERPIECE 9391319 13 X 19MM 13B

MEDTRONIC SOFAMOR DANEK, INC.

Vertebral body prosthesis, non-sterile Vertebral body prosthesis, non-sterile Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis

• Primary Device ID: 00613994676504
• NIH Device Record Key: 600bebac-600f-4b4e-9927-98da2fcde1c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T2™ Spinal System
• Version Model Number: 9391319
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Dimensions

• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 13 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994676504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100976

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

Moist Heat or Steam Sterilization

[00613994676504]

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: 2015-06-26

On-Brand Devices [T2™ Spinal System]

• 00613994676658: CENTERPIECE 9391919 19 X 19MM 19A
• 00613994676641: CENTERPIECE 9391923 19 X 23MM 19B
• 00613994676634: CENTERPIECE 9391928 19 X 28MM 19C
• 00613994676627: CENTERPIECE 9391936 19 X 36MM 19D
• 00613994676610: CENTERPIECE 9391947 19 X 47MM 19E
• 00613994676603: CENTERPIECE 9391969 19 X 69MM 19F
• 00613994676597: CENTERPIECE 9392221 22 X 21MM 22A
• 00613994676580: CENTERPIECE 9392225 22 X 25MM 22B
• 00613994676573: CENTERPIECE 9392231 22 X 31MM 22C
• 00613994676566: CENTERPIECE 9392237 22 X 37MM 22D
• 00613994676559: CENTERPIECE 9392248 22 X 48MM 22E
• 00613994676542: CENTERPIECE 9392268 22 X 68MM 22F
• 00613994676535: CENTERPIECE 9391641 16 X 41MM 16F
• 00613994676511: CENTERPIECE 9391316 13 X 16MM 13A
• 00613994676504: CENTERPIECE 9391319 13 X 19MM 13B
• 00613994676498: CENTERPIECE 9391322 13 X 22MM 13C
• 00613994676481: CENTERPIECE 9391326 13 X 26MM 13D
• 00613994676474: CENTERPIECE 9391332 13 X 32MM 13E
• 00613994676467: CENTERPIECE 9391341 13 X 41MM 13F
• 00613994676450: CENTERPIECE 9391617 16 X 17MM 16A
• 00613994676443: CENTERPIECE 9391620 16 X 20MM 16B
• 00613994676436: CENTERPIECE 9391623 16 X 23MM 16C
• 00613994676429: CENTERPIECE 9391628 16 X 28MM 16D
• 00613994676412: CENTERPIECE 9391633 16 X 33MM 16E
• 00613994676405: CENTERPIECE 9392521 25 X 21MM 25A
• 00613994676399: END CAP 9401900 19MM 0 DEGREE
• 00613994676382: END CAP 9401904 19MM 4 DEGREE
• 00613994676375: END CAP 9401908 19MM 8 DEGREE
• 00613994676368: END CAP 9401915 19MM 15 DEGREE
• 00613994676351: END CAP 9402200 22MM 0 DEGREE
• 00613994676344: END CAP 9402204 22MM 4 DEGREE
• 00613994676337: END CAP 9402208 22MM 8 DEGREE
• 00613994676320: END CAP 9402215 22MM 15 DEGREE
• 00613994676313: END CAP 9402500 25MM 0 DEGREE
• 00613994676306: END CAP 9402504 25MM 4 DEGREE
• 00613994676290: END CAP 9402508 25MM 8 DEGREE
• 00613994676283: END CAP 9402515 25MM 15 DEGREE
• 00613994676276: END CAP 9401615 16MM 15 DEGREE
• 00613994676269: CENTERPIECE 9392525 25 X 25MM 25B
• 00613994676252: CENTERPIECE 9392531 25 X 31MM 25C
• 00613994676245: CENTERPIECE 9392537 25 X 37MM 25D
• 00613994676238: CENTERPIECE 9392548 25 X 48MM 25E
• 00613994676221: CENTERPIECE 9392568 25 X 68MM 25F
• 00613994676214: END CAP 9401300 13MM 0 DEGREE
• 00613994676207: END CAP 9401304 13MM 4 DEGREE
• 00613994676191: END CAP 9401308 13MM 8 DEGREE
• 00613994676184: END CAP 9401315 13MM 15 DEGREE
• 00613994676177: END CAP 9401600 16MM 0 DEGREE
• 00613994676160: END CAP 9401604 16MM 4 DEGREE
• 00613994676153: END CAP 9401608 16MM 8 DEGREE