T2 STRATOSPHERE™ Expandable Corpectomy System

GUDID 00643169651050

ENDCAP 436020400 EXTNDED 20 X 40MM 0 DEG

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00643169651050
• NIH Device Record Key: ed27e7e8-09bd-4bbc-9850-f9d19d11747f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T2 STRATOSPHERE™ Expandable Corpectomy System
• Version Model Number: 436020400
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169651050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173125

FDA Product Code

• MQP: Spinal vertebral body replacement device

Sterilization

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

[00643169651050]

Moist Heat or Steam Sterilization

[00643169651050]

Moist Heat or Steam Sterilization

[00643169651050]

Moist Heat or Steam Sterilization

[00643169651050]

Moist Heat or Steam Sterilization

[00643169651050]

Moist Heat or Steam Sterilization

[00643169651050]

Moist Heat or Steam Sterilization

[00643169651050]

Moist Heat or Steam Sterilization

[00643169651050]

Moist Heat or Steam Sterilization

[00643169651050]

Moist Heat or Steam Sterilization

[00643169651050]

Moist Heat or Steam Sterilization

[00643169651050]

Moist Heat or Steam Sterilization

[00643169651050]

Moist Heat or Steam Sterilization

[00643169651050]

Moist Heat or Steam Sterilization

[00643169651050]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-05
• Device Publish Date: 2019-07-28

On-Brand Devices [T2 STRATOSPHERE™ Expandable Corpectomy System]

• 00643169663190: CENTERPIECE 436020D 20MM D-SIZE
• 00643169663183: CENTERPIECE 436020C 20MM C-SIZE
• 00643169663176: CENTERPIECE 436020B 20MM B-SIZE
• 00643169663169: CENTERPIECE 436020A 20MM A-SIZE
• 00643169611801: MACHINE SCREW 4369003 3MM SLOTTED
• 00763000091255: TEMPLATE NAV4362530 25MM/30MM TEMPLATE
• 00763000091248: TEMPLATE NAV4362022 20MM/22MM TEMPLATE
• 00643169611900: TEMPLATE NAV4361316 13MM/16MM TEMPLATE
• 00643169611894: INSERTER NAV4360221 20MM/25MM ANGLED
• 00643169611870: INSERTER NAV4360120 20MM/25MM INSERTER
• 00643169611863: INSERTER NAV4360113 13MM INSERTER
• 00643169611825: TEMPLATE NAV4360030 30MM EXTENDED
• 00763000168711: TRAY 4369922 STRATOSPHERE NAV INSTRMENTS
• 00643169637405: LID 4369920 20-25MM CENTERPIECE MODULE
• 00643169638518: TRAY 4369903 LATERAL TEMPLATES-IMPLANTS
• 00643169637399: MODULE 4369919 20-25MM CENTERPIECE
• 00643169663145: CENTERPIECE 436013D 13MM D-SIZE
• 00643169709461: INSERTER 4360221 20MM/25MM ANGLED
• 00643169709454: INSERTER 4360120 20MM/25MM INSERTER
• 00643169709447: INSERTER 4360113 13MM INSERTER
• 00643169611795: MACHINE SCREW 4369002 2MM SLOTTED
• 00643169709560: ENDCAP 436025455 EXTND 25 X 45MM 15 DEG
• 00643169709553: ENDCAP 436025405 EXTND 25 X 40MM 15 DEG
• 00643169709546: ENDCAP 436025355 EXTND 25 X 35MM 15 DEG
• 00643169709539: ENDCAP 436025305 EXTND 25 X 30MM 15 DEG
• 00643169709508: ENDCAP 436020355 EXTND 20 X 35MM 15 DEG
• 00643169709492: ENDCAP 436020305 EXTND 20 X 30MM 15 DEG
• 00643169663251: CENTERPIECE 436025E 25MM E-SIZE
• 00643169663244: CENTERPIECE 436025D 25MM D-SIZE
• 00643169663237: CENTERPIECE 436025C 25MM C-SIZE
• 00643169663220: CENTERPIECE 436025B 25MM B-SIZE
• 00643169663213: CENTERPIECE 436025A 25MM A-SIZE
• 00643169663206: CENTERPIECE 436020E 20MM E-SIZE
• 00643169663152: CENTERPIECE 436013E 13MM E-SIZE
• 00643169663138: CENTERPIECE 436013C 13MM C-SIZE
• 00643169663121: CENTERPIECE 436013B 13MM B-SIZE
• 00643169663114: CENTERPIECE 436013A 13MM A-SIZE
• 00643169651104: ENDCAP 436025450 EXTNDED 25 X 45MM 0 DEG
• 00643169651098: ENDCAP 436025400 EXTNDED 25 X 40MM 0 DEG
• 00643169651081: ENDCAP 436025350 EXTNDED 25 X 35MM 0 DEG
• 00643169651074: ENDCAP 436025300 EXTNDED 25 X 30MM 0 DEG
• 00643169651067: ENDCAP 436020450 EXTNDED 20 X 45MM 0 DEG
• 00643169651050: ENDCAP 436020400 EXTNDED 20 X 40MM 0 DEG
• 00643169651043: ENDCAP 436020350 EXTNDED 20 X 35MM 0 DEG
• 00643169651036: ENDCAP 436020300 EXTNDED 20 X 30MM 0 DEG
• 00643169651029: ENDCAP 4360308 30MM 8 DEGREE
• 00643169651012: ENDCAP 4360305 30MM 15 DEGREE
• 00643169651005: ENDCAP 4360300 30MM 0 DEGREE
• 00643169650992: ENDCAP 4360258 25MM 8 DEGREE
• 00643169650985: ENDCAP 4360255 25MM 15 DEGREE