VERTESTACK® Spinal System

GUDID 00613994151018

SPACER X0905257 CAPSTONE VS PEK VBS END

MEDTRONIC SOFAMOR DANEK, INC.

Vertebral body prosthesis

• Primary Device ID: 00613994151018
• NIH Device Record Key: 48b6e20e-30b7-45bd-8d5f-425a6c628196
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERTESTACK® Spinal System
• Version Model Number: X0905257
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994151018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041556

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00613994151018]

Moist Heat or Steam Sterilization

[00613994151018]

Moist Heat or Steam Sterilization

[00613994151018]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-08-19

On-Brand Devices [VERTESTACK® Spinal System]

• 00613994156402: SPACER 636953 PERIMETER XS 9X15X13MM
• 00613994156396: SPACER 636932 PERIMETER XS 9X13X12MM
• 00613994156389: SPACER 636853 PERIMETER XS 8X15X13MM
• 00613994156372: SPACER 636832 PERIMETER XS 8X13X12MM
• 00613994156365: SPACER 636753 PERIMETER XS 7X15X13MM
• 00613994156341: SPACER 636732 PERIMETER XS 7X13X12MM
• 00613994156334: SPACER 636653 PERIMETER XS 6X15X13MM
• 00613994156327: SPACER 636632 PERIMETER XS 6X13X12MM
• 00613994156310: SPACER 636553 PERIMETER XS 5X15X13MM
• 00613994156297: SPACER 636532 PERIMETER XS 5X13X12MM
• 00613994156266: SPACER 636253 PERIMETER XS 12X15X13MM
• 00613994156259: SPACER 636232 PERIMETER XS 12X13X12MM
• 00613994156242: SPACER 636153 PERIMETER XS 11X15X13MM
• 00613994156228: SPACER 636132 PERIMETER XS 11X13X12MM
• 00613994156211: SPACER 636053 PERIMETER XS 10X15X13MM
• 00613994156204: SPACER 636032 PERIMETER XS 10X13X12MM
• 00613994151018: SPACER X0905257 CAPSTONE VS PEK VBS END
• 00613994150998: SPACER X0905255 CAPSTONE VS PEK VBS END
• 00613994150974: SPACER X0905253 CAPSTONE VS PEK VBS END
• 00613994150936: SPACER X0905249 CAPSTONE VS PEK VBS END
• 00613994150899: SPACER X0905245 CAPSTONE VS PEK VBS END
• 00613994147653: SPACER X1205306 TITANIUM IMP 15MM X 30MM
• 00613994147646: SPACER X1205305 TITANIUM IMP 14MM X 30MM
• 00613994147639: SPACER X1205304 TITANIUM IMP 13MM X 30MM
• 00613994147622: SPACER X1205303 TITANIUM IMP 12MM X 30MM
• 00613994147615: SPACER X1205302 TITANIUM IMP 11MM X 30MM
• 00613994147608: SPACER X1205301 TITANIUM IMP 10MM X 30MM
• 00613994147592: SPACER X1205300 TITANIUM IMP 9MM X 30MM
• 00613994147585: SPACER X1205299 TITANIUM IMP 8 MM X 30MM
• 00613994147578: SPACER X1205298 TITANIUM IMP 7MM X 30MM
• 00613994119155: SPACER 9193615 CRESCENT PEEK 36 X 15
• 00885074308647: TELAMON P 8? 16 X 22 IMPLANT
• 00885074242132: SPACER 3393420 PRMTR LG ADD ON 12DG 20MM
• 00885074242125: SPACER 3393418 PRMTR LG ADD ON 12DG 18MM
• 00885074242101: SPACER 3393416 PRMTR LG ADD ON 12DG 16MM
• 00885074242088: SPACER 3393414 PRMTR LG ADD ON 12DG 14MM
• 00885074242071: SPACER 3393412 PRMTR LG ADD ON 12DG 12MM
• 00885074242064: SPACER 3393320 PRMTR LG ADD ON 8DG 20MM
• 00885074242057: SPACER 3393318 PRMTR LG ADD ON 8DG 18MM
• 00885074242040: SPACER 3393316 PRMTR LG ADD ON 8DG 16MM
• 00885074242026: SPACER 3393314 PRMTR LG ADD ON 8DG 14MM