T2™ Spinal System

GUDID 00613994676177

END CAP 9401600 16MM 0 DEGREE

MEDTRONIC SOFAMOR DANEK, INC.

Vertebral body prosthesis, non-sterile

• Primary Device ID: 00613994676177
• NIH Device Record Key: b7fecf66-6a17-46d1-9a3a-80da72c3d9c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T2™ Spinal System
• Version Model Number: 9401600
• 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: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter
• Angle: 0 degree
• Outer Diameter: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994676177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131888

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

Moist Heat or Steam Sterilization

[00613994676177]

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: 2015-07-27

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